Lower risk Medical device recall · FDA · Published June 3, 2021

Boston Scientific - Medical Devices, Surgical Tools, and Implants

Boston Scientific is a global leader in medical devices, surgical tools, and implants. We provide innovative solutions for cardiovascular, neurovascular, and other medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2000-2021Medical device Boston Scientific ›

Lower-risk recall

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

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Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N Bldg 3 · Saint Paul, MN 55112-5700

✎ GovInfoNow plain-language explainer

Boston Scientific is a leading global company in medical devices, surgical tools, and implants. They specialize in cardiovascular, neurovascular, and other medical procedures. Their products are used worldwide for various medical treatments. Read more at govinfonow.com/recall/62397-boston-scientific-medical-devices-surgical-tools-and-implants.

Source Summary by GovInfoNow · govinfonow.com/recall/62397-boston-scientific-medical-devices-surgical-tools-and-implants · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2000-2021

Cite this page

“Boston Scientific - Medical Devices, Surgical Tools, and Implants.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62397-boston-scientific-medical-devices-surgical-tools-and-implants. Based on FDA recall #Z-2000-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2000-2021%22&limit=1).

The FDA has issued a Class II recall for Boston Scientific Corporation's Imager II Angiographic Catheters due to a tip fracture risk.

How to tell if you have it

Boston Scientific Corporation
Imager II Angiographic Catheters

The hazard

The tip of the catheter may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

Context

This recall is classified as Class II and was initiated voluntarily by the firm on 2026-08-24. Boston Scientific Corporation has 124 other recalls on record since 2017-06-01. Recent Boston Scientific recalls include issues with LUX-Dx Cardiac Monitor Systems reported on 2026-08-06 and StoneSmart Connect Console Power Adapters reported on 2026-07-22.

How to tell if you have this one

Check for proper medical supervision, adherence to manufacturer guidelines, and regular maintenance of devices.

Brand
Boston Scientific
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1998-2021	Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131; a) L100, Serial Numbers: 464190, 464192, 464197, 464199, 464209, 464211, 464228, 464229, 464230, 464238, 464253, 464258, 464259, 464279, 464295, 464296, 464297, 464308, 464312, 464316, 464321, 464322, 464325, 464348, 464358, 464360, 464361, 464362, 464363, 464364, 464369, 464371, 464373, 464378, 464379, 464380, 464383, 464384, 464392, 464393, 464394, 464398, 464400, 464406, 464408, 464409, 464410, 464411, 464412, 464414, 464415, 464421, 464425, 464427, 464428, 464430, 464431, 464432, 464435, 464437, 464440, 464441, 464442, 464443, 464445, 464451, 464455, 464456, 464465, 464466, 464469, 464474, 464480, 464484, 464485, 464487, 464488, 464489, 464493, 464496, 464502, 464503, 464504, 464507, 464520, 464529, 464531, 464534, 464538, 464544, 464546, 464547, 464551, 464556, 464558, 464560, 464566, 464567, 464571, 464573, 464577, 464578, 464583, 464585, 464586, 464587, 464588, 464591, 464592, 464598, 464599, 464604, 464608, 464609, 464611, 464616, 464617, 464623, 464625, 464629, 464635, 464637, 464639, 464642, 464643, 464644, 464647, 464650, 464653, 464656, 464657, 464659, 464660, 464662, 464664, 464665, 464666, 464667, 464668, 464672, 464681, 464683, 464684, 464685, 464692, 464697, 464698, 464699, 464700, 464723, 464725, 464726, 464730, 464732, 464734, 464735, 464736, 464738, 464740, 464741, 464742, 464758, 464760, 464761, 464762, 464772, 464814, 464816, 464818, 464819, 464820, 464821, 464824, 464825, 464826, 464828, 464829, 464830, 464831, 464833, 464835, 464836, 464837, 464838, 464839, 464843, 464844, 464848, 464849, 464851, 464852, 464870, 464873, 464880, 464883, 464884, 464888, 464891, 464892, 464893, 464899, 464900, 464901, 464902, 464926, 465020, 465058, 465101, 465118, 465121, 465147, 465171, 465179, 465187, 465190, 465191, 465196, 465203, 465204, 465205, 465215, 465217, 465219, 465225, 465228, 465230, 465231, 465239, 465243, 465244, 465254, 465255, 465256, 465263, 465265, 465267, 465269, 465272, 465275, 465277, 465278, 465280, 465291, 465295, 465298, 465308, 465310, 465313, 465315, 465321, 465323, 465324, 465325, 465327, 465328, 465330, 465331, 465333, 465335, 465337, 465338, 465339, 465341, 465342, 465345, 465346, 465349, 465350, 465355, 465356, 465360, 465363, 465364, 465365, 465368, 465369, 465374, 465375, 465379, 465388, 465390, 465393, 465395, 465398, 465401, 465405, 465409, 465413, 465500, 465673, 465747, 465752, 465830, 465832, 465833, 465837, 465851, 465852, 465853, 465868, 465870, 465877, 465878, 465881, 465883, 465889, 465905, 465923, 465925, 465937, 465951, 465955, 465956, 465964, 465966, 465967, 465968, 465969, 465970, 465971, 465973, 465975, 465979, 465980, 465982, 465985, 465988, 465990, 465991, 465993, 465994, 465996, 465998, 465999, 466000, 466003, 466008, 466011, 466012, 466013, 466014, 466015, 466018, 466019, 466020, 466028, 466029, 466032, 466033, 466034, 466037, 466038, 466041, 466043, 466044, 466046, 466048, 466051, 466052, 466054, 466055, 466056, 466060, 466064, 466067, 466069, 466070, 466071, 466075, 466077, 466079, 466084, 466086, 466087, 466088, 466089, 466091, 466092, 466096, 466099, 466100, 466106, 466109, 466110, 466111, 466112, 466114, 466117, 466121, 466123, 466125, 466128, 466129, 466131, 466132, 466136, 466138, 466139, 466141, 466143, 466145, 466146, 466150, 466152, 466154, 466157, 466162, 466167, 466168, 466169, 466170, 466173, 466174, 466176, 466177, 466181, 466185, 466187, 466192, 466193, 466194, 466197, 466199, 466202, 700002, 700015, 700016, 700019, 700022, 700024, 700031, 700033, 700038, 700047, 700048, 700076, 700083, 700088, 700094, 700098, 700100, 700117, 700123, 700128, 700133, 700143, 700144, 700148, 700150, 700154, 700159, 700161, 700164, 700172, 700180, 700193, 700235, 700252, 700260, 700415, 700453, 700638, 700664, 700681, 700692, 700708, 700716, 700730, 700731, 700743, 700760, 700767, 700771, 700776, 700784, 700785, 700786, 700791, 700807, 700812, 700819, 700824, 700828, 700830, 700839, 700842, 700843, 700858, 700860, 700867, 700869, 700870, 700872, 700874, 700885, 700887, 700890, 700903, 700907, 700911, 700920, 700922, 700924, 700927, 700932, 700935, 700937, 700942, 700945, 700946, 700951, 700958, 700961, 700963, 700964, 700966, 700970, 700973, 700974, 700989, 700990, 700991, 700992, 701001, 701004, 701047, 701051, 701053, 701055, 701058, 701070, 701071, 701073, 701074, 701075, 701085, 701087, 701104, 701105, 701112, 701121, 701125, 701128, 701138, 701142, 701165, 701169, 701170, 701176, 701179, 701180, 701186, 701198, 701203, 701219, 701228, 701229, 701232, 701250, 701257, 701258, 701266, 701268, 701270, 701276, 701277, 701290, 701297, 701298, 701315, 701317, 701318, 701326, 701338, 701360, 701362, 701377, 701384, 701392, 701403, 701409, 701415, 701425, 701434, 701440, 701441, 701442, 701444, 701445, 701447, 701451, 701454, 701457, 701459, 701465, 701469, 701479, 701481, 701490, 701493, 701494, 701500, 701501, 701503, 701513, 701515, 701516, 701518, 701519, 701527, 701535, 701536, 701537, 701538, 701545, 701551, 701553, 701559, 701562, 701563, 701564, 701565, 701566, 701568, 701570, 701573, 701575, 701578, 701580, 701584, 701587, 701588, 701590, 701591, 701593, 701596, 701597, 701598, 701600, 701606, 701609, 701610, 701619, 701621, 701624, 701627, 701629, 701635, 701636, 701638, 701645, 701649, 701650, 701651, 701658, 701662, 701672, 701682, 701686, 701687, 701690, 701692, 701694, 701695, 701698, 701702, 701710, 701711, 701712, 701714, 701722, 701734, 701744, 701775, 701780, 701782, 701808, 701811, 701821, 701849, 701853, 701867, 701875, 701888, 701896, 701897, 701900, 701901, 701905, 701911, 701912, 701917, 701925, 701928, 701935, 701936, 701937, 701938, 701945, 701952, 701957, 701958, 701959, 701960, 701961, 701962, 701969, 701974, 701977, 701979, 701980, 701984, 701989, 701991, 702000, 702003, 702007, 702008, 702009, 702012, 702015, 702016, 702021, 702038, 702041, 702044, 702055, 702064, 702075, 702098, 702112, 702113, 702119, 702122, 702123, 702135, 702137, 702138, 702139, 702144, 702145, 702153, 702159, 702176, 702177, 702179, 702180, 702182, 702184, 702186, 702188, 702195, 702202, 702203, 702210, 702224, 702228, 702241, 702242, 702243, 702244, 702246, 702255, 702257, 702258, 702261, 702266, 702271, 702272, 702273, 702276, 702278, 702279, 702281, 702285, 702288, 702289, 702290, 702470, 702482, 702487, 702583, 702640, 702651, 702653, 702663, 702713, 702717, 702731, 702739, 702742, 702750, 702772, 702792, 702794, 702809, 702811, 702831, 702833, 702843, 702883, 702884, 702890, 702928, 702942, 702963, 702970, 702972, 702991, 703001, 703008, 703009, 703021, 703022, 703048, 703052, 703065, 703084, 703097, 703101, 703124, 703129, 703136, 703138, 703151, 703152, 703153, 703160, 703170, 703188, 703195, 703197, 703203, 703204, 703227, 703247, 703253, 703254, 703255, 703256, 703261, 703262, 703269, 703271, 703275, 703276, 703283, 703286, 703287, 703290, 703293, 703295, 703303, 703305, 703306, 703311, 703312, 703316, 703324, 703336, 703346, 703349, 703355, 703357, 703363, 703378, 703381, 703383, 703386, 703391, 703397, 703417, 703418, 703643, 703658, 703756, 703774, 703818, 703823, 703834, 703854, 703882, 703883, 703887, 703901, 703911, 703912, 703920, 703943, 703952, 703957, 703958, 703968, 703976, 703978, 703984, 703999, 704021, 704023, 704034, 704036, 704043, 704054, 704098, 704104, 704110, 704111, 704112, 704120, 704130, 704132, 704135, 704137, 704139, 704148, 704152, 704159, 704165, 704166, 704170, 704174, 704177, 704183, 704184, 704186, 704189, 704197, 704200, 704201, 704202, 704203, 704208, 704216, 704220, 704221, 704224, 704231, 704242, 704245, 704248, 704254, 704256, 704260, 704270, 704277, 704278, 704291, 704325, 704330, 704331, 704334, 704340, 704343, 704345, 704347, 704348, 704351, 704354, 704358, 704359, 704360, 704368, 704372, 704374, 704375, 704377, 704379, 704381, 704384, 704386, 704389, 704882, 705022, 705024, 705086, 705162, 705204, 705206, 705207, 705220, 705224, 705227, 705240, 705241, 705242, 705249, 705250, 705251, 705252, 705265, 705269, 705270, 705273, 705283, 705286, 705288, 705289, 705290, 705292, 705293, 705299, 705304, 705307, 705322, 705323, 705325, 705339, 705349, 705351, 705368, 705373, 705382, 705385, 705386, 705389, 705390, 705392, 705396, 705397, 705408, 705410, 705412, 705414, 705421, 705424, 705425, 705430, 705434, 705435, 705438, 705441, 705446, 705452, 705457, 705459, 705464, 705469, 705485, 705487, 705488, 705490, 705492, 705496, 705497, 705499, 705500, 705508, 705512, 705513, 705518, 705519, 705520, 705522, 705528, 705529, 705536, 705537, 705539, 705540, 705545, 705549, 705553, 705559, 705561, 705564, 705569, 705578, 705582, 705592, 705594, 705598, 705600, 705601, 705607, 705608, 705615, 705617, 705619, 705633, 705634, 705636, 705637, 705638, 705640, 705643, 705645, 705700, 705708, 705709, 705710, 705712, 705720, 705725, 705727, 705729, 705731, 705742, 705744, 705755, 705756, 705758, 705764, 705793, 705794, 705805, 705806, 705816, 705824, 705827, 705832, 705840, 705844, 705845, 705865, 705883, 705901, 705905, 705906, 705909, 705912, 705916, 705921, 705935, 705943, 705974, 705975, 705984, 705985, 706037, 706038, 706039, 706046, 706053, 706056, 706059, 706062, 706082, 706096, 706102, 706108, 706125, 706129, 706132, 706155, 706161, 706163, 706167, 706182, 706186, 706191, 706193, 706210, 706213, 706218, 706219, 706225, 706238, 706266, 706274, 706281, 706301, 706302, 706309, 706345, 706354, 706374, 706381, 706391, 706393, 706398, 706407, 706415, 706438, 706443, 706451, 706457, 706463, 706467, 706472, 706475, 706496, 706508, 706510, 706539, 706569, 706605, 706606, 706648, 706668, 706674, 706680, 706707, 706709, 706748, 706753, 706772, 706780, 706789, 706791, 706792, 706824, 706829, 706837, 706842, 706845, 706852, 706863, 706868, 706869, 706872, 706954, 706958, 706960, 707001, 707038, 707043, 707047, 707068, 707071, 707077, 707079, 707088, 707105, 707124, 707146, 707150, 707156, 707160, 707161, 707163, 707190, 707209, 707210, 707212, 707217, 707221, 707225, 707245, 707247, 707249, 707251, 707256, 707258, 707268, 707274, 707276, 707287, 707288, 707290, 707304, 707306, 707323, 707329, 707344, 707345, 707355, 707356, 707357, 707362, 707366, 707369, 707372, 707373, 707379, 707381, 707384, 707402, 707411, 707438, 707445, 707454, 707455, 707461, 707472, 707473, 707474, 707477, 707487, 707494, 707498, 707500, 707502, 707504, 707506, 707509, 707511, 707525, 707528, 707537, 707543, 707544, 707545, 707557, 707560, 707569, 707577, 707582, 707584, 707596, 707597, 707604, 707606, 707608, 707614, 707619, 707620, 707631, 707632, 707638, 707639, 707642, 707645, 707656, 707662, 707666, 707682, 707695, 707698, 707699, 707704, 707708, 707720, 707723, 707747, 707748, 707752, 707756, 707758, 707766, 707786, 707787, 707795, 707802, 707804, 707806, 707814, 707822, 707826, 707827, 707838, 707848, 707858, 707860, 707866, 707868, 707894, 707895, 707920, 707923, 708151, 708223, 708230, 708245, 708247, 708248, 708253, 708258, 708264, 708275, 708279, 708286, 708291, 708304, 708306, 708307, 708325, 708327, 708330, 708344, 708346, 708348, 708353, 708354, 708361, 708363, 708365, 708367, 708375, 708378, 708381, 708424, 708425, 708434, 708437, 708446, 708553, 708561, 708587, 708592, 708597, 708608, 708614, 708616, 708632, 708644, 708647, 708763, 708779, 708784, 708791, 708796, 708806, 708810, 708813, 708829, 708830, 708833, 708835, 708838, 708846, 708861, 708869, 708873, 708900, 708902, 708904, 708957, 708996, 709018, 709035, 709070, 709074, 709081, 709087, 709099, 709113, 709123, 709131, 709145, 709148, 709160, 709166, 709180, 709181, 709182, 709186, 709196, 709201, 709203, 709204, 709205, 709206, 709207, 709208, 709210, 709211, 709213, 709216, 709218, 709224, 709225, 709226, 709233, 709234, 709238, 709243, 709244, 711767, 711769, 711775, 711783, 711796, 711816, 711820, 711821, 711829, 711830, 711835, 711841, 711846, 711847, 711849, 711862, 711864, 711884, 711886, 711896, 711905, 711913, 711920, 711936, 711937, 711943, 711944, 711945, 711950… Full codes in the FDA record	31548 units
Z-1999-2021	Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231; a) L200, Serial Numbers: 464370, 464446, 464458, 464460, 464462, 464468, 464470, 464475, 464481, 464482, 464483, 464490, 464498, 464500, 464508, 464512, 464516, 464519, 464526, 464528, 464532, 464563, 464590, 705134, 705580, 705587, 705711, 705751, 706215, 708261, 708589, 708797, 708798, 708802, 708815, 708819, 708820, 708832, 708841, 708843, 708844, 708848, 708851, 708858, 708859, 708874, 708877, 708883, 708886, 708892, 708896, 708907, 708910, 708913, 708914, 708917, 708923, 708928, 708932, 708933, 708935, 708936, 708937, 708938, 708940, 708941, 708943, 708956, 708958, 708963, 708974, 708977, 708981, 708982, 708986, 708987, 709002, 709004, 709006, 709007, 709008, 709013, 709016, 709027, 709033, 709034, 709039, 709042, 709044, 709045, 711776, 711780, 711795, 711804, 711814, 711823, 711839, 711852, 711866, 711868, 711875, 711893, 711894, 711899, 711914, 711917, 711925, 711938, 711947, 711954, 711971, 711997, 712053, 712056, 712084, 712086, 712088, 712093, 712098, 712125, 712129, 712131, 712174, 712177, 712178, 712219, 712232, 712239, 712249, 712257, 712279, 712284, 712286, 712290, 712350, 712352, 712385, 712390, 712410, 712414, 712428, 712436, 712442, 712449, 712470, 712475, 712489, 712491, 712521, 712537, 712571, 712598, 712631, 712848, 713367, 714102, 714105, 714785, 719943, 720012, 720109, 720110, 720119, 720142, 720228, 464359, 464382, 464387, 464388, 464444, 464447, 464452, 464457, 464467, 464471, 464473, 464477, 464486, 464491, 464492, 464501, 464505, 464506, 464511, 464514, 464517, 464521, 464523, 464525, 464527, 464541, 464549, 464552, 464554, 464561, 464568, 464570, 464576, 464694, 705236, 705383, 705409, 705419, 705462, 705468, 705555, 705563, 705576, 705579, 705584, 705591, 705622, 705628, 705702, 705706, 705713, 705728, 705753, 705795, 705812, 706007, 706098, 706200, 706256, 706321, 706328, 706350, 706372, 706379, 706392, 706441, 706698, 706846, 706879, 706918, 706923, 706931, 706947, 706967, 707053, 707069, 707089, 707138, 707173, 708351, 708585, 708595, 708618, 708619, 708620, 708764, 708816, 708824, 708826, 708831, 708853, 708857, 708862, 708867, 708868, 708879, 708880, 708885, 708887, 708889, 708894, 708898, 708905, 708912, 708915, 708916, 708918, 708920, 708922, 708924, 708925, 708929, 708930, 708939, 708942, 708944, 708945, 708946, 708947, 708948, 708949, 708950, 708952, 708959, 708960, 708965, 708966, 708967, 708968, 708969, 708971, 708975, 708976, 708978, 708980, 708983, 708984, 708992, 708997, 709000, 709003, 709009, 709014, 709023, 709024, 709025, 709029, 709037, 709040, 709041, 709043, 711763, 711765, 711768, 711771, 711773, 711777, 711791, 711843, 711863, 711865, 711867, 711869, 711870, 711872, 711879, 711885, 711887, 711890, 711897, 711898, 711910, 711915, 711918, 711922, 711923, 711924, 711926, 711927, 711928, 711929, 711931, 711942, 711946, 711963, 711965, 711970, 711980, 711982, 711987, 712009, 712017, 712026, 712058, 712083, 712107, 712114, 712137, 712145, 712210, 712255, 712256, 712264, 712302, 712312, 712321, 712396, 712397, 712459, 712477, 712534, 712742, 712820, 712829, 712843, 713710, 714062, 714791, 714827, 715058, 719969, 719972, 720019, 720122, 720124, 720132, 720134, 720135, 720141, 720144, 720145, 720147, 720172, 720173, 720183, 720184, 720191, 720198, 720234, 720240, 720242, 720250, 720309. b) L201, Serial Numbers: 100197, 100197, 716267, 716291, 716760, 716845, 716997, 718600, 718990, 742235, 742270, 742333, 742343, 742359, 742372, 742390, 742461, 742514, 742556, 742588, 742625, 742754, 743187, 743229, 743329, 743535, 744054, 746443, 746451, 751482, 100140, 100164, 100165, 100174, 100181, 100186, 100221, 100243, 100282, 100287, 100290, 100401, 100407, 100410, 100707, 100750, 100827, 100838, 100839, 716162, 716208, 716288, 716289, 716290, 716309, 716419, 716421, 716423, 716424, 716426, 716435, 716605, 716629, 716641, 716715, 716750, 716759, 716769, 716779, 716803, 716836, 716868, 716990, 716994, 717000, 717009, 717034, 717040, 717053, 717070, 717077, 717083, 717098, 717099, 717108, 717118, 717124, 717153, 717156, 717166, 717182, 717189, 717197, 717248, 717250, 717274, 717302, 717306, 717310, 717314, 717369, 717378, 717413, 717491, 717504, 717525, 717533, 717570, 717577, 717583, 717593, 717600, 717653, 717700, 717816, 717877, 717878, 717885, 717896, 717906, 717917, 717931, 717963, 717978, 717991, 717994, 717996, 718005, 718021, 718137, 718242, 718418, 718492, 718494, 718504, 718528, 718552, 718558, 718601, 718605, 718608, 718617, 718627, 718630, 718631, 718640, 718659, 718667, 718668, 718672, 718675, 718676, 718680, 718683, 718697, 718705, 718711, 718713, 718716, 718733, 718743, 718747, 718748, 718762, 718775, 718778, 718784, 718794, 718801, 718805, 718806, 718807, 718820, 718831, 718833, 718852, 718860, 718868, 718881, 718882, 718883, 718890, 718892, 718893, 718894, 718896, 718900, 718901, 718908, 718914, 718915, 718931, 718972, 718979, 718989, 719003, 719014, 719016, 719045, 719948, 724869, 725647, 725651, 725749, 725774, 725775, 725787, 725949, 726012, 726021, 726027, 726030, 726077, 726083, 726100, 726115, 726129, 726151, 726160, 726176, 726178, 726197, 726202, 726255, 726268, 726278, 726385, 726393, 726425, 726436, 726489, 726496, 726529, 726546, 726552, 726563, 726569, 726576, 726580, 726596, 726600, 726650, 726688, 726708, 726710, 726717, 726718, 726723, 726728, 726733, 726736, 726747, 726790, 726791, 726806, 726822, 727141, 727202, 741730, 741837, 741928, 741931, 741970, 741985, 741986, 741988, 742029, 742031, 742033, 742045, 742079, 742086, 742100, 742107, 742141, 742206, 742209, 742215, 742216, 742220, 742225, 742256, 742265, 742267, 742274, 742281, 742295, 742297, 742324, 742331, 742337, 742341, 742351, 742363, 742367, 742376, 742379, 742402, 742415, 742431, 742432, 742433, 742435, 742436, 742443, 742444, 742449, 742451, 742475, 742491, 742520, 742532, 742536, 742548, 742566, 742606, 742607, 742613, 742614, 742618, 742620, 742621, 742640, 742667, 742677, 742699, 742712, 742741, 742746, 742748, 742758, 742786, 742815, 742849, 742858, 742866, 742878, 742885, 742931, 742932, 742960, 742985, 743012, 743064, 743073, 743086, 743093, 743102, 743106, 743107, 743137, 743141, 743205, 743253, 743288, 743301, 743328, 743343, 743353, 743362, 743372, 743383, 743384, 743397, 743454, 743456, 743460, 743461, 743462, 743477, 743755, 743958, 744006, 744048, 744049, 744050, 744051, 744052, 744053, 744056, 744057, 744060, 744090, 750690, 750843, 750853, 751125, 751350, 751443, 751479, 751488, 751497, 751630, 752204, 752207. c) L209, Serial Numbers: 701098, 701123, 701125, 701142, 100002, 100006, 100007, 100008, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100017, 100019, 100020, 100021, 100022, 100023, 100025, 100026, 100027, 100028, 100029, 100030, 100031, 100032, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100119, 100120, 100121, 100123, 100124, 100125, 100126, 100127, 100129, 100130, 100131, 100132, 100133, 100134, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100143, 100144, 100148, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100172, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100184, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100195, 700001, 700002, 700003, 700004, 700005, 700006, 700007, 700008, 700009, 700010, 700011, 700012, 700013, 700014, 700015, 700016, 700017, 700018, 700019, 700020, 700021, 700022, 700023, 700024, 700025, 700026, 700027, 700028, 700029, 700030, 700031, 700032, 700033, 700034, 700035, 700036, 700037, 700038, 700039, 700040, 700041, 700042, 700043, 700044, 700046, 700047, 700048, 700050, 700051, 700053, 700054, 700055, 700056, 700057, 700058, 700059, 700060, 700061, 700062, 700063, 700064, 700065, 700066, 700067, 700068, 700069, 700070, 700071, 700072, 700073, 700189, 700190, 700191, 700192, 700193, 700194, 700195, 700196, 700197, 700198, 700200, 700201, 700202, 700203, 700204, 700205, 700206, 700207, 700208, 700209, 700210, 700211, 700212, 700213, 700215, 700216, 700217, 700218, 700219, 700220, 700221, 700222, 700223, 700224, 700225, 700226, 700227, 700228, 700229, 700230, 700232, 700233, 700234, 700235, 700236, 700237, 700238, 700239, 700240, 700241, 700242, 700243, 700244, 700245, 700247, 700248, 700249, 700250, 700251, 700252, 700253, 700254, 700255, 700256, 700257, 700258, 700260, 700261, 700262, 700263, 700264, 700265, 700266, 700267, 700268, 700270, 700271, 700272, 700273, 700274, 700275, 700276, 700278, 700279, 700280, 700281, 700282, 700283, 700284, 700285, 700286, 700287, 700288, 700289, 700290, 700292, 700293, 700294, 700295, 700296, 700297, 700298, 700299, 700300, 700301, 700302, 700303, 700304, 700313, 700314, 700315, 700316, 700317, 700318, 700338, 700339, 700345, 700346, 700347, 700348, 700349, 700350, 700351, 700352, 700353, 700354, 700355, 700356, 700357, 700358, 700359, 700360, 700361, 700362, 700363, 700364, 700365, 700574, 700575, 700576, 700577, 700578, 700579, 700580, 700581, 700582, 700583, 700584, 700585, 700588, 700589, 700590, 700591, 700592, 700593, 700594, 700595, 701094, 701095, 701096, 701097, 701099, 701100, 701101, 701102, 701103, 701104, 701105, 701106, 701107, 701108, 701110, 701111, 701112, 701113, 701114, 701115, 701116, 701117, 701118, 701119, 701120, 701121, 701122, 701124, 701126, 701127, 701128, 701129, 701130, 701131, 701132, 701133, 701134, 701135, 701136, 701137, 701138, 701139, 701140, 701141, 701143. d) L210, Serial Numbers:100509, 100768, 100790, 101609, 700737, 700845, 701136, 701278, 701488, 701507, 701646, 701792, 702081, 702174, 702200, 702409, 702470, 702471, 702559, 702695, 702876, 702976, 703944, 705103, 705140, 705151, 705396, 705413, 705506, 705647, 705649, 705652, 705655, 705656, 705658, 705664, 705667, 705669, 705675, 705676, 705677, 705681, 705684, 705702, 705709, 705710, 705717, 705719, 705722, 705724, 705727, 705729, 705732, 705762, 705770, 705776, 705779, 705782, 705789, 705795, 705818, 705822, 705884, 705886, 705893, 705917, 705943, 706085, 706088, 706143, 706180, 706288, 706562, 706877, 706887, 706962, 706971, 706982, 706994, 706996, 707006, 707028, 707041, 707083, 707097, 707102, 707147, 707490, 707614, 708065, 708067, 708149, 708170, 708608, 708615, 709083, 709111, 709126, 709145, 709147, 709149, 709153, 709164, 709167, 709170, 709176, 709228, 709241, 709261, 709276, 709288, 709303, 709314, 709328, 709357, 709362, 709421, 709424, 709442, 709448, 709472, 709654, 709761, 709786, 709792, 709906, 709964, 710449, 715197, 715375, 715384, 715480, 717555, 718798, 718994, 720561, 720603, 720775, 720888, 720892, 721226, 721232, 721253, 721256, 721289, 721293, 721456, 721472, 721493, 721657, 724720, 724770, 724836, 724841, 724919, 724926, 724931, 724936, 724953, 724970, 724982, 724986, 724989, 725026, 725056, 725099, 725139, 725163, 725201, 725223, 725290, 725321, 725365, 725379, 725414, 725417, 725420, 725433, 725435, 725438, 725450, 725451, 725477, 725562, 725645, 725710, 725711, 725712, 725745, 725838, 725848, 725850, 725854, 725855, 725938, 726174, 727121, 727122, 727125, 727752, 749889, 750720, 750721, 750728, 750757, 750764, 750851, 750946, 751365, 751554, 751645, 751693, 751729, 751756, 751761, 751776, 751909, 751952, 752031, 752264, 100002, 100009, 100010, 100011, 100012, 100014, 100017, 100020, 100021, 100023… Full codes in the FDA record	21756 units
Z-2000-2021	Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331; a) L300, Serial Numbers: 712118, 713277, 713352, 713357, 713365, 713381, 713390, 713398, 713403, 713405, 713406, 713420, 713440, 713443, 713447, 713454, 713456, 713459, 713461, 713464, 713469, 713470, 713474, 713480, 713483, 713500, 713501, 713506, 713508, 713513, 713515, 713516, 713519, 713528, 713530, 713538, 713542, 713543, 713544, 713548, 713592, 713593, 713614, 713621, 713624, 713625, 713630, 713631, 713633, 713637, 713642, 713646, 713649, 713650, 713651, 713652, 713666, 713669, 713675, 713682, 713695, 713701, 713711, 713719, 713728, 713732, 713738, 713744, 713755, 713766, 713796, 713799, 713842, 714095, 714101, 714274, 714280, 719937, 719963, 719998, 720049, 720218, 720222, 720253, 720280, 707669, 713278, 713312, 713318, 713319, 713320, 713326, 713333, 713335, 713363, 713368, 713372, 713385, 713386, 713388, 713389, 713393, 713399, 713401, 713404, 713407, 713408, 713409, 713411, 713414, 713419, 713426, 713431, 713445, 713446, 713449, 713450, 713453, 713457, 713458, 713460, 713462, 713463, 713468, 713471, 713473, 713475, 713476, 713479, 713481, 713485, 713486, 713487, 713488, 713490, 713492, 713494, 713495, 713496, 713497, 713499, 713503, 713504, 713505, 713507, 713509, 713510, 713518, 713522, 713523, 713524, 713529, 713531, 713532, 713534, 713539, 713540, 713550, 713551, 713552, 713554, 713556, 713558, 713559, 713561, 713563, 713564, 713565, 713566, 713567, 713568, 713569, 713570, 713572, 713575, 713576, 713578, 713579, 713580, 713583, 713584, 713586, 713587, 713590, 713591, 713613, 713615, 713616, 713617, 713619, 713620, 713622, 713623, 713635, 713638, 713639, 713640, 713643, 713655, 713656, 713657, 713659, 713661, 713662, 713664, 713665, 713667, 713668, 713670, 713671, 713672, 713673, 713676, 713677, 713681, 713683, 713686, 713687, 713689, 713694, 713697, 713698, 713702, 713705, 713706, 713707, 713708, 713709, 713712, 713714, 713716, 713717, 713724, 713727, 713729, 713730, 713733, 713735, 713739, 713741, 713742, 713743, 713746, 713749, 713750, 713753, 713756, 713758, 713760, 713763, 713767, 713768, 713771, 713773, 713774, 713775, 713776, 713777, 713779, 713780, 713781, 713782, 713786, 713787, 713788, 713789, 713790, 713791, 713792, 713794, 713795, 713797, 713798, 713801, 713802, 713803, 713805, 713806, 713807, 713808, 713809, 713813, 713814, 713815, 713816, 713817, 713820, 713822, 713823, 713824, 713825, 713827, 713828, 713829, 713830, 713831, 713832, 713833, 713849, 713853, 713858, 713859, 713863, 713866, 713971, 713988, 714040, 714046, 714050, 714055, 714056, 714058, 714060, 714061, 714085, 714096, 714104, 714107, 714111, 719820, 719959, 719960, 719965, 719970, 719977, 720008, 720013, 720015, 720026, 720030, 720034, 720037, 720040, 720123, 720239, 720278 b) L301, Serial Numbers: 100547, 100752, 100822, 100829, 100843, 100845, 100846, 100850, 100852, 100853, 100857, 100863, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100874, 100875, 100876, 100878, 100879, 100881, 100883, 100884, 100889, 100890, 100891, 100892, 100893, 100894, 100895, 100896, 100897, 100899, 100900, 100903, 100904, 100911, 100912, 100913, 100914, 100915, 100916, 100919, 100920, 100921, 100923, 100925, 100926, 100927, 100928, 100929, 100930, 100931, 100932, 100936, 100937, 100938, 100939, 100940, 100941, 100942, 100944, 100946, 100947, 100948, 100949, 100950, 100952, 100955, 100956, 100957, 100958, 100959, 100960, 100962, 100964, 100967, 100968, 100969, 100970, 100971, 100972, 100973, 100975, 100976, 100977, 100979, 100980, 100981, 100982, 100983, 100985, 100986, 100988, 100989, 100990, 100991, 100993, 100994, 100995, 100996, 100997, 100999, 101000, 101002, 101003, 101004, 101006, 101008, 101009, 101010, 101011, 101012, 101014, 101015, 101016, 101017, 101018, 101020, 101021, 101022, 101024, 101025, 101032, 101033, 101034, 101036, 101037, 101039, 101040, 101042, 101043, 101044, 101046, 101048, 101050, 101052, 101053, 101059, 101060, 101061, 101063, 101064, 101065, 101066, 101067, 101068, 101069, 101072, 101073, 101074, 101075, 101076, 101078, 101080, 101082, 101083, 101086, 101087, 101088, 101089, 101090, 101091, 101092, 101093, 101096, 101097, 101098, 101099, 101101, 101103, 101104, 101105, 101106, 101108, 101109, 101110, 101111, 101113, 101114, 101118, 101120, 101122, 101125, 101126, 101127, 101129, 101130, 101131, 101132, 101133, 101134, 101135, 101136, 101137, 101138, 101140, 101141, 101142, 101143, 101144, 101148, 101149, 101152, 101153, 101154, 101155, 101157, 101158, 101159, 101161, 101165, 101170, 101173, 101174, 101176, 101177, 101178, 101179, 101180, 101181, 101182, 101184, 101185, 101186, 101187, 101190, 101191, 101193, 101200, 101202, 101207, 101208, 101209, 101210, 101211, 101214, 101218, 101221, 101223, 101224, 101225, 101227, 101228, 101229, 101231, 101233, 101234, 101235, 101236, 101238, 101242, 101243, 101244, 101245, 101246, 101247, 101249, 101251, 101254, 101258, 101261, 101262, 101263, 101264, 101267, 101268, 101270, 101271, 101272, 101274, 101275, 101276, 101279, 101283, 101285, 101286, 101288, 101289, 101290, 101292, 101293, 101294, 101297, 101299, 101300, 101303, 101309, 101310, 101313, 101314, 101315, 101316, 101317, 101318, 101320, 101321, 101322, 101323, 101325, 101328, 101330, 101331, 101332, 101334, 101335, 101336, 101337, 101338, 101343, 101344, 101345, 101348, 101350, 101354, 101359, 101360, 101361, 101362, 101372, 101373, 101374, 101378, 101379, 101380, 101382, 101386, 101387, 101388, 101393, 101398, 101400, 101402, 101406, 101407, 101409, 101411, 101412, 101413, 101415, 101416, 101418, 101419, 101423, 101424, 101426, 101427, 101434, 101436, 101437, 101438, 101440, 101442, 101447, 101448, 101450, 101451, 101452, 101454, 101455, 101457, 101458, 101459, 101462, 101466, 101467, 101469, 101471, 101472, 101475, 101483, 101488, 101492, 101493, 101494, 101495, 101497, 101502, 101503, 101504, 101505, 101508, 101509, 101511, 101514, 101517, 101523, 101524, 101525, 101526, 101528, 101529, 101530, 101533, 101534, 101535, 101537, 101539, 101541, 101543, 101545, 101546, 101547, 101550, 101553, 101555, 101559, 101560, 101564, 101567, 101569, 101572, 101573, 101574, 101575, 101576, 101577, 101579, 101581, 101583, 101584, 101585, 101587, 101588, 101589, 101590, 101593, 101599, 101602, 101603, 101604, 101605, 101607, 101609, 101610, 101611, 101612, 101614, 101615, 101616, 101617, 101619, 101625, 101626, 101627, 101629, 101630, 101633, 101634, 101637, 101638, 101639, 101640, 101642, 101643, 101644, 101648, 101651, 101652, 101654, 101655, 101656, 101657, 101658, 101659, 101660, 101661, 101663, 101668, 101670, 101672, 101674, 101675, 101676, 101677, 101684, 101687, 101698, 101699, 101700, 101704, 101705, 101706, 101720, 101726, 101728, 101730, 101733, 101734, 101736, 101737, 101741, 101749, 101751, 101764, 101767, 101769, 101771, 101779, 101781, 101783, 101786, 101788, 101790, 101795, 101796, 101797, 101805, 101806, 101807, 101811, 101819, 101821, 101823, 101825, 101828, 101834, 101840, 101841, 101842, 101844, 101846, 101848, 101851, 101852, 101862, 101873, 101889, 101911, 101912, 101919, 101927, 101928, 101929, 101930, 101931, 101938, 101941, 101942, 101943, 101946, 101947, 101948, 101951, 101953, 101955, 101957, 101966, 101967, 101968, 101970, 101973, 101982, 101985, 101987, 101988, 101990, 101992, 101994, 101996, 101998, 102002, 102006, 102007, 102008, 102009, 102010, 102011, 102014, 102015, 102017, 102019, 102022, 102023, 102025, 102028, 102030, 102031, 102032, 102033, 102034, 102035, 102036, 102039, 102040, 102042, 102043, 102044, 102047, 102048, 102057, 102058, 102064, 102068, 102070, 102071, 102073, 102074, 102076, 102079, 102080, 102081, 102082, 102084, 102085, 102087, 102089, 102090, 102091, 102093, 102094, 102095, 102096, 102097, 102098, 102101, 102104, 102105, 102109, 102112, 102113, 102115, 102116, 102118, 102125, 102126, 102128, 102129, 102132, 102134, 102138, 102142, 102144, 102146, 102147, 102148, 102149, 102150, 102152, 102153, 102154, 102155, 102156, 102157, 102160, 102161, 102162, 102164, 102166, 102167, 102172, 102176, 102177, 102180, 102183, 102184, 102185, 102186, 102187, 102188, 102189, 102191, 102192, 102196, 102198, 102201, 102203, 102205, 102207, 102209, 102210, 102211, 102213, 102215, 102216, 102222, 102223, 102231, 102236, 102237, 102238, 102242, 102243, 102246, 102247, 102248, 102250, 102252, 102253, 102255, 102257, 102258, 102259, 102260, 102263, 102264, 102267, 102268, 102269, 102270, 102271, 102273, 102274, 102277, 102278, 102281, 102283, 102284, 102285, 102288, 102289, 102290, 102291, 102293, 102294, 102295, 102297, 102299, 102301, 102302, 102303, 102305, 102308, 102309, 102310, 102311, 102312, 102315, 102316, 102317, 102318, 102319, 102322, 102323, 102325, 102326, 102327, 102329, 102331, 102332, 102334, 102335, 102336, 102337, 102338, 102339, 102341, 102342, 102343, 102344, 102345, 102346, 102348, 102350, 102352, 102353, 102355, 102356, 102359, 102360, 102361, 102362, 102363, 102364, 102365, 102366, 102367, 102370, 102371, 102372, 102373, 102374, 102376, 102379, 102381, 102382, 102383, 102384, 102386, 102387, 102388, 102392, 102393, 102395, 102400, 102401, 102404, 102406, 102407, 102408, 102409, 102410, 102411, 102413, 102415, 102416, 102421, 102422, 102424, 102426, 102427, 102430, 102431, 102435, 102437, 102438, 102439, 102440, 102441, 102442, 102443, 102445, 102446, 102447, 102448, 102449, 102451, 102452, 102453, 102454, 102461, 102463, 102465, 102467, 102468, 102470, 102471, 102472, 102473, 102474, 102478, 102481, 102484, 102485, 102486, 102487, 102490, 102491, 102492, 102493, 102494, 102496, 102497, 102498, 102499, 102506, 102507, 102508, 102510, 102512, 102513, 102515, 102516, 102517, 102518, 102520, 102521, 102522, 102523, 102524, 102525, 102526, 102528, 102530, 102532, 102534, 102536, 102538, 102540, 102542, 102543, 102545, 102547, 102553, 102557, 102562, 102575, 102577, 102578, 102579, 102584, 102586, 102590, 102592, 102593, 102602, 102606, 102612, 102613, 102617, 102629, 102631, 102634, 102640, 102646, 102652, 102665, 102669, 102676, 102682, 102687, 102688, 102689, 102691, 102692, 102699, 102703, 102709, 102710, 102713, 102714, 102716, 102719, 102721, 102724, 102725, 102731, 102733, 102734, 102735, 102736, 102738, 102746, 102755, 102761, 102771, 102773, 102782, 102792, 102795, 102798, 102810, 102811, 102815, 102816, 102817, 102823, 102825, 102828, 102830, 102832, 102833, 102834, 102839, 102840, 102841, 102842, 102843, 102844, 102845, 102846, 102848, 102854, 102855, 102860, 102861, 102863, 102866, 102867, 102868, 102872, 102873, 102876, 102885, 102888, 102889, 102891, 102897, 102901, 102902, 102907, 102908, 102910, 102911, 102914, 102915, 102916, 102919, 102922, 102923, 102926, 102927, 102929, 102930, 102935, 102937, 102950, 102956, 102964, 102968, 102971, 102973, 102974, 102979, 102981, 102990, 102991, 102997, 102998, 102999, 103000, 103009, 103018, 103031, 103041, 103046, 103047, 103048, 103049, 103050, 103062, 103063, 103065, 103067, 103068, 103071, 103072, 103074, 103076, 103087, 103090, 103096, 103098, 103114, 103115, 103117, 103118, 103123, 103128, 103130, 103132, 103148, 103163, 103165, 103181, 103185, 103190, 103200, 103202, 103203, 103204, 103205, 103206, 103207, 103208, 103209, 103212, 103213, 103215, 103216, 103221, 103225, 103232, 103236, 103239, 103259, 103260, 103261, 103262, 103275, 103281, 103283, 103285, 103292, 103293, 103295, 103301, 700002, 700008, 700013, 700019, 700020, 700022, 700025, 700027, 700029, 700030, 700031, 700033, 700037, 700041, 700042, 700043, 700044, 700045, 700046, 700049, 700050, 700054, 700057, 700059, 700062, 700070, 700071, 700078, 700079, 700084, 700085, 700086, 700087, 700091, 700092, 700093, 700094, 700095, 700096, 700097, 700099, 700103, 700107, 700108, 700110, 700116, 700118, 700141, 700144, 700149, 700151, 700152, 700157, 700162, 700166, 700171, 700176, 700178, 700181, 700183, 700184, 700185, 700187, 700190, 700191, 700194, 700195, 700196, 700197, 700198, 700200, 700202, 700213, 700216, 700220, 700225… Full codes in the FDA record	70074 units
Z-2001-2021	Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722; a) S701, Serial Numbers: 100005, 100011, 100012, 100015, 100017, 100021, 100022, 100028, 100032, 100034, 100037, 100053, 100055, 100059, 100060, 100068, 100075, 100079, 100082, 100083, 100090, 100095, 100098, 100103, 100106, 100116, 100119, 100122, 100124, 100128, 100132, 100135, 100139, 100141, 100148, 100149, 100205, 100208, 100211, 100213, 100221, 100230, 100231, 100232, 100234, 100236, 100238, 100239, 100245, 100247, 100251, 100252, 100254, 100255, 100262, 100265, 100269, 100303, 100305, 100306, 100311, 100348, 100366, 100377, 100378, 100380, 100383, 100390, 100391, 100392, 100393, 100394, 100395, 100396, 100399, 100400, 100401, 100403, 100405, 100406, 700002, 700003, 700004, 700005, 700006, 700008, 700010, 700021, 700022, 700023, 700024, 700025, 700026, 700027, 700028, 700029, 700031, 700036, 700037, 700039, 700040, 700042, 700043, 700044, 700046, 700047, 700048, 700049, 700050, 700051, 700055, 700062, 700067, 700081, 700083, 700084, 700086, 700089, 700091, 700092, 700093, 700095, 700096, 700097, 700100, 700102, 700103, 700104, 700105, 700106, 700107, 700109, 700111, 700112, 700117, 700118, 700120, 700123, 700124, 700125, 700127, 700128, 700129, 700130, 700133, 700136, 700137, 700138, 700139, 700141, 700144, 700145, 700147, 700148, 700149, 700150, 700151, 700152, 700153, 700155, 700156, 700160, 700162, 700163, 700164, 700167, 700169, 700170, 700171, 700173, 700176, 700177, 700181, 700182, 700184, 700187, 700188, 700189, 700306, 700309, 700310, 700311, 700312, 700313, 700316, 700317, 700318, 700329, 700334, 700335, 700336, 700337, 700338, 700339, 700340, 700344, 700345, 700346, 700353, 700355, 700356, 700357, 700359, 700360, 700362, 700363, 700364, 700366, 700368, 700369, 700371, 700373, 700388, 700389, 700390, 700392, 700393, 700394, 700396, 700397, 700399, 700403, 700404, 700643, 700709, 700710, 700712, 700721, 700725, 700735, 700736, 700737, 700738, 700740, 700741, 700742, 700744, 700745, 700747, 700748, 700770, 700772, 700776, 700777, 700785, 700786, 700788, 700791, 700793, 700795, 700796, 700797, 700799, 700801, 700802, 700804, 700805, 700818, 700823, 700835, 700836, 700848, 700849, 700855, 700856, 700860, 700861, 700864, 700865, 700867, 700871, 700873, 700874, 700879, 700881, 700887, 700898, 700912, 700917, 700931, 700932, 700935, 700937, 700938, 700939, 700950, 700951, 700952, 700955, 700958, 700960, 700961, 700962, 700970, 700976, 700979, 700989, 701007, 701008, 701012, 701021, 701026, 701029, 701032, 701033, 701038, 701042, 701051, 701053, 701055, 701059, 701061, 701062, 701063, 701071, 701073, 701074, 701077, 701078, 701080, 701081, 701082, 701091, 701097, 701098, 701099, 701100, 701106, 701132, 701136, 701137, 701138, 701139, 701141, 701144, 701146, 701151, 701156, 701157, 701161, 701167, 701172, 701178, 702097, 702104, 702131, 702138, 702165, 702167, 702220, 702223, 702298, 702299, 702300, 702301, 702304, 702318, 702320, 702321, 702322, 702323, 702325, 702327, 704574, 704583, 704590, 704593, 704594, 704598, 704599, 704600, 704631, 704637, 704639, 704642, 100002, 100003, 100004, 100007, 100008, 100009, 100010, 100013, 100014, 100016, 100018, 100019, 100020, 100023, 100025, 100026, 100027, 100030, 100031, 100033, 100035, 100036, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100054, 100056, 100057, 100058, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100069, 100070, 100071, 100072, 100073, 100076, 100077, 100078, 100081, 100084, 100085, 100086, 100087, 100088, 100091, 100092, 100093, 100094, 100096, 100097, 100099, 100100, 100101, 100102, 100104, 100109, 100111, 100112, 100114, 100115, 100117, 100118, 100120, 100121, 100123, 100126, 100127, 100129, 100130, 100131, 100133, 100136, 100137, 100138, 100140, 100142, 100143, 100144, 100145, 100146, 100147, 100150, 100151, 100152, 100153, 100154, 100155, 100156, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100195, 100196, 100197, 100198, 100200, 100201, 100202, 100203, 100206, 100210, 100212, 100214, 100215, 100216, 100218, 100219, 100220, 100222, 100224, 100225, 100228, 100229, 100235, 100237, 100240, 100241, 100242, 100243, 100244, 100246, 100248, 100249, 100250, 100257, 100259, 100260, 100263, 100266, 100267, 100268, 100270, 100271, 100272, 100275, 100278, 100279, 100280, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100294, 100295, 100296, 100298, 100300, 100301, 100302, 100307, 100308, 100310, 100312, 100314, 100315, 100316, 100317, 100318, 100321, 100342, 100349, 100353, 100354, 100355, 100356, 100357, 100358, 100359, 100360, 100361, 100362, 100364, 100365, 100367, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100379, 100381, 100382, 100384, 100385, 100386, 100387, 100388, 100389, 100397, 100402, 100404, 700001, 700030, 700032, 700033, 700034, 700035, 700041, 700045, 700052, 700053, 700054, 700056, 700057, 700058, 700059, 700060, 700063, 700065, 700066, 700068, 700069, 700070, 700071, 700072, 700073, 700074, 700075, 700077, 700078, 700079, 700080, 700082, 700085, 700087, 700088, 700090, 700094, 700098, 700099, 700101, 700108, 700110, 700113, 700114, 700115, 700116, 700119, 700121, 700126, 700131, 700132, 700134, 700135, 700142, 700143, 700146, 700157, 700158, 700159, 700165, 700166, 700168, 700172, 700174, 700178, 700179, 700180, 700191, 700304, 700305, 700330, 700331, 700332, 700333, 700341, 700342, 700343, 700351, 700352, 700354, 700358, 700365, 700367, 700370, 700374, 700387, 700391, 700395, 700398, 700400, 700401, 700402, 700634, 700639, 700640, 700641, 700642, 700659, 700660, 700661, 700662, 700663, 700664, 700665, 700666, 700667, 700668, 700669, 700711, 700713, 700714, 700715, 700716, 700719, 700720, 700722, 700723, 700724, 700739, 700749, 700750, 700763, 700764, 700765, 700766, 700767, 700768, 700769, 700771, 700773, 700774, 700775, 700778, 700787, 700789, 700790, 700792, 700794, 700798, 700800, 700803, 700819, 700820, 700821, 700822, 700824, 700825, 700826, 700827, 700828, 700829, 700830, 700831, 700832, 700833, 700837, 700838, 700839, 700840, 700841, 700842, 700843, 700844, 700845, 700846, 700847, 700850, 700857, 700858, 700859, 700862, 700863, 700866, 700868, 700869, 700870, 700872, 700875, 700876, 700877, 700878, 700880, 700882, 700883, 700884, 700885, 700886, 700899, 700900, 700901, 700902, 700903, 700904, 700905, 700906, 700907, 700908, 700909, 700910, 700911, 700913, 700914, 700915, 700916, 700918, 700919, 700920, 700921, 700922, 700923, 700924, 700925, 700926, 700927, 700928, 700929, 700930, 700933, 700934, 700936, 700940, 700948, 700949, 700953, 700954, 700956, 700957, 700959, 700963, 700964, 700965, 700966, 700967, 700968, 700971, 700972, 700973, 700977, 700978, 700981, 700982, 700983, 700990, 700991, 700992, 700993, 700994, 700995, 700996, 700997, 700998, 701005, 701006, 701009, 701010, 701011, 701013, 701014, 701015, 701016, 701017, 701018, 701022, 701023, 701024, 701025, 701027, 701028, 701030, 701031, 701034, 701035, 701036, 701037, 701039, 701040, 701041, 701049, 701050, 701052, 701054, 701056, 701057, 701058, 701060, 701064, 701065, 701066, 701067, 701068, 701069, 701070, 701072, 701075, 701076, 701079, 701083, 701084, 701085, 701086, 701089, 701090, 701093, 701094, 701095, 701096, 701109, 701120, 701121, 701130, 701131, 701133, 701134, 701135, 701140, 701142, 701143, 701145, 701147, 701148, 701149, 701150, 701152, 701153, 701154, 701155, 701159, 701160, 701162, 701163, 701164, 701165, 701166, 701168, 701169, 701170, 701171, 701173, 701174, 701175, 701176, 701177, 701179, 701180, 701181, 701182, 702127, 702128, 702129, 702130, 702132, 702133, 702134, 702135, 702136, 702137, 702139, 702140, 702141, 702163, 702164, 702166, 702170, 702171, 702172, 702179, 702180, 702191, 702192, 702193, 702194, 702219, 702221, 702222, 702296, 702297, 702302, 702303, 702319, 702326, 704566, 704567, 704568, 704569, 704570, 704571, 704572, 704573, 704575, 704582, 704584, 704585, 704586, 704587, 704588, 704589, 704591, 704592, 704595, 704596, 704597, 704601, 704602, 704603, 704604, 704606, 704607, 704608, 704609, 704610, 704611, 704628, 704629, 704630, 704633, 704634, 704635, 704636, 704638, 704640, 704641, 704643, 704644, 704645, 704646, 704647 b) S702, Serial Numbers: 100010, 100042, 100054, 100082, 100084, 100097, 100101, 100111, 100119, 100126, 100146, 100148, 100152, 100155, 100165, 100167, 100172, 100173, 100174, 100182, 100184, 100191, 100194, 100196, 100203, 100206, 100207, 100208, 100209, 100210, 100215, 100219, 100221, 100223, 100229, 100232, 100235, 100237, 100239, 100242, 100243, 100246, 100255, 100257, 100258, 100261, 100262, 100270, 100273, 100277, 100286, 100290, 100292, 100293, 100297, 100298, 100312, 100319, 100327, 100330, 100331, 100332, 100336, 100341, 100343, 100344, 100346, 100349, 100352, 100357, 100363, 100365, 100387, 100393, 100401, 100402, 100403, 100406, 100410, 100502, 100551, 100555, 100573, 100608, 100619, 100643, 100680, 100698, 100714, 100758, 100799, 100843, 100849, 100850, 100851, 100858, 100860, 100864, 100865, 100875, 100879, 100909, 100911, 100921, 100922, 100924, 700081, 700097, 700105, 700111, 700113, 700121, 700193, 700199, 700208, 700209, 700210, 700214, 700230, 700233, 700236, 700238, 700240, 700242, 700252, 700258, 700269, 700270, 700282, 700288, 700702, 700807, 700810, 700867, 700868, 700871, 700875, 700885, 700888, 700899, 700901, 700906, 700907, 700915, 700918, 700919, 700922, 700925, 700926, 700927, 700934, 700937, 700942, 700944, 700948, 700951, 700954, 700959, 700964, 700974, 700979, 700984, 700991, 700996, 701003, 701006, 701015, 701016, 701018, 701021, 701030, 701031, 701056, 701057, 701063, 701065, 701073, 701075, 701077, 701082, 701097, 701102, 701105, 701108, 701109, 701111, 701115, 701117, 701119, 701120, 701126, 701128, 701129, 701130, 701131, 701132, 701133, 701136, 701138, 701139, 701141, 701143, 701144, 701146, 701148, 701153, 701154, 701155, 701156, 701160, 701161, 701164, 701165, 701167, 701172, 701173, 701174, 701175, 701177, 701179, 701181, 701184, 701193, 701196, 701197, 701202, 701203, 701206, 701211, 701212, 701213, 701218, 701220, 701221, 701226, 701227, 701228, 701229, 701230, 701231, 701232, 701233, 701234, 701235, 701753, 703262, 703265, 703271, 703281, 703293, 703294, 703306, 703307, 703318, 703322, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100009, 100011, 100012, 100013, 100014, 100015, 100016, 100017, 100018, 100020, 100021, 100025, 100026, 100028, 100029, 100030, 100031, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100040, 100045, 100046, 100050, 100051, 100052, 100053, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100062, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100077, 100078, 100079, 100080, 100081, 100083, 100085, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100093, 100094, 100095, 100096, 100098, 100099, 100100, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100112, 100113, 100115, 100116, 100117, 100118, 100120, 100121, 100122, 100123, 100124, 100125, 100128, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100143, 100144, 100145, 100147, 100149, 100150, 100151, 100153, 100154, 100156, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100166, 100168, 100170, 100171, 100175, 100176, 100177, 100179, 100180, 100181, 100183, 100185, 100186, 100187, 100188, 100189, 100190, 100192, 100193, 100195, 100197, 100198, 100199, 100200, 100201, 100202, 100204, 100205, 100211, 100212, 100213, 100214, 100216, 100217, 100218, 100220, 100222, 100224, 100225, 100226, 100227, 100228, 100230, 100231, 100234… Full codes in the FDA record	2952 units
Z-2002-2021	VALITUDE CRT-P pacemaker, Models: a) U125 b) U128; a) U125, Serial Numbers: 100009, 100057, 100074, 100257, 100521, 700037, 700061, 700068, 700074, 700172, 700179, 700190, 700253, 702556, 702777, 702999, 703683, 703806, 704048, 707332, 707470, 707508, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100010, 100011, 100013, 100015, 100020, 100024, 100026, 100028, 100029, 100033, 100050, 100054, 100058, 100062, 100063, 100066, 100067, 100068, 100069, 100071, 100076, 100079, 100081, 100084, 100085, 100086, 100091, 100102, 100106, 100110, 100133, 100136, 100146, 100148, 100149, 100150, 100157, 100159, 100163, 100164, 100165, 100171, 100175, 100188, 100192, 100199, 100200, 100201, 100202, 100203, 100205, 100208, 100209, 100210, 100211, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100222, 100224, 100226, 100228, 100231, 100234, 100235, 100237, 100244, 100245, 100248, 100249, 100250, 100251, 100253, 100256, 100265, 100267, 100268, 100272, 100274, 100275, 100277, 100279, 100283, 100284, 100290, 100308, 100317, 100391, 100416, 100417, 100426, 100450, 100451, 100507, 100509, 100511, 100512, 100520, 100556, 100606, 100621, 100662, 100663, 100665, 100668, 100709, 100739, 100741, 100796, 100797, 100815, 100816, 100820, 100831, 100836, 100838, 100839, 100848, 100855, 100857, 100859, 100862, 100863, 100867, 100872, 100882, 100885, 100898, 100899, 100903, 100911, 100914, 100918, 100920, 100927, 100936, 100937, 700001, 700004, 700005, 700008, 700009, 700010, 700011, 700012, 700014, 700017, 700019, 700020, 700022, 700023, 700026, 700028, 700029, 700031, 700034, 700036, 700038, 700041, 700049, 700051, 700053, 700054, 700055, 700057, 700058, 700062, 700065, 700069, 700070, 700076, 700079, 700086, 700087, 700090, 700091, 700093, 700095, 700097, 700098, 700101, 700107, 700111, 700112, 700113, 700114, 700119, 700123, 700127, 700129, 700131, 700133, 700135, 700136, 700137, 700139, 700144, 700147, 700154, 700158, 700161, 700162, 700163, 700164, 700166, 700167, 700168, 700169, 700171, 700173, 700174, 700175, 700176, 700177, 700178, 700181, 700182, 700183, 700184, 700185, 700187, 700192, 700193, 700194, 700195, 700196, 700199, 700204, 700208, 700219, 700223, 700224, 700228, 700229, 700230, 700231, 700232, 700233, 700236, 700237, 700238, 700240, 700241, 700242, 700244, 700247, 700248, 700251, 700254, 700255, 700257, 700258, 700259, 700260, 700263, 700265, 700266, 700267, 700269, 700275, 700276, 700282, 700283, 700287, 700289, 700290, 700518, 700521, 700589, 700675, 700700, 700702, 700746, 700747, 700759, 700771, 700786, 700806, 700823, 700848, 700850, 700859, 700875, 700879, 701243, 701258, 701276, 701342, 701352, 701380, 701388, 701394, 701442, 701517, 702420, 702440, 702447, 702451, 702452, 702460, 702479, 702480, 702487, 702490, 702491, 702492, 702493, 702496, 702497, 702499, 702500, 702503, 702504, 702519, 702532, 702533, 702535, 702538, 702550, 702551, 702554, 702563, 702571, 702572, 702575, 702577, 702583, 702585, 702589, 702598, 702599, 702605, 702608, 702611, 702613, 702614, 702625, 702633, 702642, 702647, 702670, 702675, 702677, 702681, 702683, 702684, 702697, 702739, 702750, 702761, 702766, 702767, 702798, 702833, 702856, 702866, 702872, 702879, 702964, 702966, 702970, 702974, 702978, 702982, 702984, 702987, 702993, 703001, 703008, 703009, 703010, 703034, 703054, 703113, 703140, 703260, 703261, 703274, 703680, 703684, 703706, 703718, 703728, 703736, 703742, 703748, 703753, 703782, 703787, 703791, 703792, 703793, 703797, 703798, 703799, 703800, 703801, 703802, 703803, 703805, 703807, 703811, 703813, 703818, 703819, 703820, 703821, 703824, 703828, 703829, 703832, 703833, 703834, 703836, 703837, 703839, 703843, 703851, 703853, 703856, 703857, 703859, 703870, 703877, 703887, 703947, 703962, 703963, 704003, 704030, 704032, 704039, 704043, 704060, 704088, 705122, 705124, 705126, 705128, 705130, 705134, 705137, 707314, 707315, 707317, 707318, 707319, 707331, 707343, 707345, 707350, 707368, 707370, 707371, 707372, 707410, 707412, 707413, 707421, 707422, 707442, 707443, 707446, 707447, 707450, 707455, 707458, 707460, 707462, 707468, 707471, 707472, 707478, 707484, 707496, 707518, 707527, 707529, 707536, 707556, 707557, 707565, 707573, 707575, 707582, 707601, 707603, 707612, 707614, 707627 b) U128, Serial Numbers: 100184, 100187, 100217, 100222, 100236, 100240, 100247, 100251, 100253, 100256, 100260, 100262, 100274, 100275, 100277, 100289, 100308, 100317, 100328, 100330, 100331, 100338, 100339, 100346, 100350, 100351, 100355, 100357, 100359, 100361, 100363, 100364, 100369, 100371, 100372, 100373, 100376, 100377, 100378, 100379, 100380, 100381, 100383, 100386, 100389, 100390, 100391, 100392, 100393, 100394, 100397, 100399, 100400, 100401, 100402, 100404, 100405, 100409, 100410, 100411, 100413, 100414, 100417, 100419, 100420, 100433, 100435, 100437, 100438, 100444, 100445, 100447, 100449, 100450, 100452, 100453, 100454, 100456, 100458, 100459, 100461, 100463, 100466, 100468, 100471, 100473, 100474, 100475, 100476, 100478, 100479, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100489, 100491, 100492, 100497, 100499, 100500, 100501, 100502, 100503, 100504, 100506, 100507, 100510, 100511, 100513, 100514, 100519, 100520, 100522, 100523, 100524, 100526, 100527, 100529, 100531, 100533, 100535, 100536, 100537, 100539, 100541, 100544, 100545, 100547, 100550, 100551, 100552, 100553, 100555, 100556, 100557, 100560, 100562, 100563, 100564, 100565, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100580, 100581, 100583, 100586, 100588, 100589, 100590, 100592, 100593, 100595, 100596, 100600, 100601, 100602, 100605, 100607, 100608, 100609, 100615, 100616, 100617, 100618, 100619, 100620, 100621, 100624, 100626, 100627, 100640, 100641, 100646, 100654, 100669, 100672, 100677, 100678, 100683, 100686, 100730, 100731, 100732, 100735, 100736, 100737, 100744, 100759, 100761, 100762, 100763, 100765, 100768, 100769, 100772, 100773, 100774, 100775, 100776, 100777, 100778, 100783, 100784, 100785, 100787, 100788, 100791, 100792, 100793, 100794, 100795, 100798, 100799, 100801, 100804, 100805, 100806, 100807, 100808, 100817, 100839, 100840, 100841, 100842, 100881, 100882, 100889, 100907, 100939, 100941, 100971, 100972, 100974, 100975, 100977, 100979, 100980, 100982, 100983, 100984, 100985, 100987, 100988, 100989, 100990, 100991, 100992, 100993, 100994, 100995, 100998, 101000, 101001, 101002, 101003, 101004, 101005, 101007, 101009, 101011, 101012, 101014, 101018, 101021, 101022, 101024, 101026, 101027, 101038, 101039, 101041, 101044, 101045, 101048, 101052, 101054, 101056, 101057, 101058, 101066, 101069, 101072, 101089, 101102, 101103, 101104, 101107, 101109, 101110, 101115, 101116, 101117, 101118, 101120, 101121, 101122, 101125, 101127, 101128, 101129, 101130, 101131, 101133, 101134, 101135, 101136, 101137, 101138, 101139, 101140, 101142, 101143, 101146, 101147, 101148, 101159, 101169, 101171, 101174, 101176, 101177, 101180, 101181, 101184, 101186, 101199, 101206, 101233, 101242, 101244, 101250, 101251, 101254, 101255, 101256, 101259, 101260, 101261, 101266, 101267, 101269, 101281, 101282, 101283, 101285, 101289, 101290, 101291, 101292, 101293, 101301, 101303, 101304, 101306, 101309, 101311, 101312, 101313, 101316, 101318, 101325, 101326, 101328, 101329, 101330, 101333, 101334, 101335, 101337, 101338, 101341, 101343, 101345, 101350, 101353, 101354, 101355, 101358, 101360, 101362, 101363, 101367, 101369, 101371, 101374, 101375, 101377, 101387, 101389, 101395, 101398, 101401, 101404, 101407, 101410, 101411, 101412, 101414, 101415, 101416, 101417, 101427, 101428, 101442, 101445, 101462, 101464, 101470, 101472, 101473, 101474, 101482, 101484, 101486, 101489, 101492, 101493, 101509, 101516, 101518, 101525, 101552, 101553, 101621, 101639, 101644, 101659, 101729, 101744, 101746, 101747, 101760, 101774, 101776, 101777, 101778, 101781, 101789, 101802, 101838, 101841, 101844, 101848, 101868, 101870, 101871, 101881, 101890, 101892, 101911, 101921, 101932, 101934, 101948, 101950, 101954, 101962, 101963, 101965, 101966, 101968, 101977, 101979, 101983, 101987, 101989, 101993, 102002, 102003, 102005, 102008, 102010, 102011, 102012, 102013, 102014, 102015, 102017, 102021, 102022, 102026, 102028, 102032, 102033, 102035, 102036, 102037, 102039, 102050, 102051, 102053, 102054, 102057, 102058, 102060, 102061, 102063, 102064, 102065, 102066, 102067, 102069, 102070, 102071, 102073, 102076, 102078, 102079, 102082, 102085, 102088, 102089, 102091, 102092, 102093, 102097, 102099, 102102, 102103, 102106, 102109, 102117, 102121, 102126, 102127, 102128, 102132, 102137, 102138, 102144, 102147, 102150, 102154, 102166, 102168, 102170, 102180, 102182, 102190, 102191, 102196, 102198, 102210, 102212, 102213, 102225, 102226, 102230, 102233, 102234, 102237, 102243, 102245, 102247, 102248, 102252, 102258, 102263, 102291, 102292, 102296, 102301, 102312, 102315, 102317, 102327, 102328, 102371, 102416, 102431, 102437, 102440, 102448, 102453, 102455, 102457, 102458, 102462, 102469, 102470, 102472, 102473, 700065, 700091, 700105, 700169, 700194, 700206, 700222, 700233, 700242, 700244, 700245, 700252, 700256, 700258, 700264, 700267, 700270, 700272, 700273, 700278, 700279, 700296, 700304, 700306, 700307, 700308, 700310, 700311, 700312, 700313, 700316, 700318, 700322, 700323, 700324, 700325, 700327, 700328, 700329, 700330, 700332, 700339, 700340, 700341, 700343, 700346, 700349, 700350, 700353, 700354, 700355, 700356, 700358, 700359, 700360, 700361, 700363, 700364, 700365, 700366, 700367, 700374, 700378, 700379, 700380, 700388, 700389, 700392, 700398, 700399, 700407, 700408, 700415, 700417, 700418, 700421, 700424, 700427, 700428, 700434, 700436, 700439, 700441, 700445, 700446, 700447, 700450, 700452, 700453, 700456, 700458, 700459, 700460, 700474, 700486, 700487, 700490, 700491, 700501, 700504, 700520, 700677, 700678, 700679, 700687, 700690, 700691, 700694, 700699, 700700, 700702, 700705, 700707, 700708, 700713, 700716, 700717, 700719, 700720, 700723, 700788, 700789, 700790, 700792, 700794, 700796, 700797, 700800, 700801, 700803, 700806, 700807, 700808, 700810, 700814, 700815, 700816, 700817, 700818, 700820, 700822, 700823, 700824, 700827, 700829, 700830, 700831, 700833, 700834, 700835, 700837, 700839, 700840, 700897, 700898, 700901, 700904, 700906, 700909, 700910, 700911, 700913, 700914, 700915, 700916, 700918, 700920, 700921, 700924, 700927, 700932, 700935, 700936, 700971, 700972, 700975, 700976, 700977, 700978, 700979, 700980, 700981, 700982, 700983, 700984, 700985, 700987, 700988, 700991, 700992, 700994, 700995, 700996, 700997, 700998, 701000, 701001, 701004, 701005, 701006, 701007, 701008, 701009, 701011, 701013, 701019, 701020, 701021, 701022, 701023, 701026, 701028, 701029, 701032, 701035, 701038, 701039, 701041, 701042, 701045, 701046, 701047, 701049, 701050, 701051, 701052, 701053, 701054, 701057, 701058, 701059, 701063, 701067, 701068, 701070, 701072, 701073, 701078, 701079, 701080, 701081, 701083, 701084, 701087, 701088, 701094, 701095, 701097, 701098, 701099, 701101, 701102, 701105, 701106, 701109, 701111, 701112, 701113, 701117, 701119, 701121, 701124, 701125, 701127, 701129, 701130, 701132, 701133, 701136, 701141, 701144, 701146, 701147, 701149, 701150, 701151, 701152, 701153, 701154, 701155, 701156, 701158, 701161, 701162, 701166, 701168, 701169, 701171, 701173, 701175, 701178, 701179, 701180, 701182, 701183, 701188, 701189, 701190, 701193, 701194, 701195, 701196, 701199, 701206, 701207, 701208, 701209, 701210, 701211, 701214, 701218, 701221, 701223, 701224, 701225, 701226, 701228, 701230, 701231, 701232, 701233, 701234, 701235, 701236, 701246, 701247, 701250, 701251, 701253, 701254, 701255, 701256, 701259, 701262, 701263, 701264, 701267, 701271, 701272, 701294, 701295, 701296, 701299, 701300, 701302, 701304, 701308, 701312, 701313, 701314, 701315, 701316, 701317, 701322, 701324, 701326, 701330, 701332, 701333, 701335, 701336, 701337, 701339, 701340, 701341, 701342, 701343, 701344, 701345… Full codes in the FDA record	6377 units
Z-2003-2021	VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228; a) U225, Serial Numbers: 707340, 100094, 100142, 100152, 100160, 100184, 100309, 100364, 100807, 100880, 100908, 100913, 700015, 700197, 700469, 700559, 700563, 700576, 700586, 700598, 700613, 700655, 700681, 700682, 700722, 700725, 700782, 700824, 700895, 700942, 700961, 700998, 701017, 701030, 701045, 701094, 701118, 701127, 701212, 701230, 701264, 701336, 701339, 701343, 701407, 701477, 701504, 702448, 702462, 702471, 702654, 702673, 702685, 702809, 703137, 703696, 703697, 703784, 703827, 703875, 703883, 703998, 707324, 707337, 707338, 707347, 707348, 707398, 707430, 707477, 707502, 707503, 707505, 707510, 707511, 707512, 707522, 707524, 707538, 707546, 707566, 707587, 707590, 707597, 100016, 100021, 100023, 100048, 100053, 100059, 100060, 100061, 100064, 100065, 100070, 100072, 100073, 100075, 100077, 100082, 100087, 100088, 100089, 100090, 100093, 100097, 100098, 100100, 100101, 100103, 100105, 100107, 100108, 100109, 100113, 100114, 100115, 100116, 100117, 100118, 100120, 100121, 100122, 100123, 100125, 100126, 100128, 100129, 100130, 100131, 100134, 100135, 100137, 100138, 100140, 100143, 100144, 100145, 100147, 100151, 100153, 100154, 100155, 100156, 100161, 100168, 100169, 100170, 100172, 100173, 100174, 100176, 100181, 100183, 100185, 100186, 100187, 100190, 100191, 100195, 100196, 100197, 100198, 100233, 100238, 100241, 100252, 100266, 100269, 100271, 100273, 100276, 100278, 100282, 100289, 100293, 100296, 100304, 100312, 100313, 100316, 100388, 100395, 100398, 100424, 100428, 100471, 100543, 100545, 100579, 100581, 100595, 100602, 100604, 100610, 100616, 100627, 100712, 100717, 100720, 100734, 100747, 100787, 100800, 100804, 100806, 100810, 100819, 100827, 100828, 100832, 100834, 100835, 100845, 100849, 100850, 100851, 100852, 100853, 100856, 100858, 100865, 100874, 100879, 100887, 100888, 100889, 100890, 100892, 100894, 100895, 100900, 100901, 100902, 100905, 100906, 100907, 100909, 100915, 100916, 100917, 100919, 100921, 100922, 100923, 100924, 100926, 100928, 100929, 100930, 100931, 100932, 100933, 100934, 100935, 700002, 700006, 700013, 700016, 700021, 700024, 700025, 700027, 700035, 700039, 700040, 700043, 700044, 700047, 700048, 700052, 700056, 700060, 700063, 700064, 700067, 700071, 700075, 700077, 700080, 700082, 700083, 700084, 700085, 700088, 700089, 700092, 700094, 700099, 700100, 700102, 700103, 700104, 700105, 700108, 700109, 700110, 700115, 700121, 700125, 700128, 700132, 700134, 700138, 700142, 700145, 700146, 700148, 700151, 700152, 700153, 700155, 700156, 700157, 700159, 700160, 700165, 700170, 700180, 700188, 700189, 700198, 700202, 700203, 700205, 700206, 700209, 700210, 700211, 700214, 700215, 700216, 700217, 700221, 700222, 700225, 700246, 700249, 700268, 700271, 700274, 700278, 700279, 700281, 700285, 700288, 700291, 700292, 700389, 700425, 700427, 700428, 700429, 700430, 700431, 700432, 700433, 700434, 700435, 700446, 700447, 700448, 700449, 700450, 700451, 700452, 700453, 700454, 700455, 700457, 700458, 700459, 700461, 700462, 700463, 700464, 700465, 700467, 700468, 700470, 700471, 700472, 700473, 700474, 700475, 700476, 700477, 700478, 700479, 700480, 700481, 700482, 700483, 700484, 700485, 700486, 700487, 700490, 700491, 700492, 700493, 700494, 700495, 700496, 700497, 700498, 700499, 700500, 700503, 700504, 700506, 700508, 700510, 700511, 700512, 700513, 700514, 700515, 700516, 700522, 700523, 700524, 700525, 700526, 700527, 700528, 700529, 700530, 700531, 700532, 700533, 700534, 700535, 700536, 700537, 700538, 700540, 700541, 700542, 700543, 700544, 700545, 700546, 700547, 700548, 700549, 700550, 700551, 700553, 700555, 700558, 700560, 700561, 700562, 700564, 700566, 700567, 700568, 700570, 700571, 700572, 700573, 700574, 700575, 700577, 700578, 700579, 700580, 700581, 700583, 700584, 700585, 700587, 700588, 700590, 700591, 700592, 700593, 700594, 700595, 700596, 700597, 700599, 700600, 700603, 700604, 700605, 700606, 700607, 700608, 700609, 700610, 700611, 700612, 700614, 700615, 700616, 700617, 700620, 700622, 700623, 700624, 700625, 700626, 700627, 700628, 700629, 700631, 700632, 700633, 700635, 700636, 700637, 700639, 700640, 700641, 700642, 700643, 700644, 700645, 700647, 700648, 700651, 700652, 700653, 700654, 700658, 700659, 700660, 700661, 700663, 700664, 700665, 700666, 700667, 700668, 700670, 700671, 700672, 700673, 700674, 700676, 700677, 700679, 700680, 700683, 700684, 700686, 700687, 700688, 700689, 700690, 700691, 700693, 700694, 700695, 700696, 700698, 700699, 700704, 700705, 700710, 700711, 700712, 700714, 700715, 700716, 700717, 700718, 700719, 700720, 700723, 700724, 700727, 700728, 700729, 700730, 700731, 700732, 700733, 700734, 700736, 700737, 700739, 700740, 700741, 700742, 700743, 700745, 700748, 700749, 700750, 700751, 700752, 700753, 700754, 700755, 700756, 700757, 700758, 700760, 700761, 700764, 700766, 700767, 700768, 700770, 700772, 700773, 700774, 700775, 700776, 700778, 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701423, 701425, 701426, 701427, 701428, 701429, 701430, 701431, 701433, 701435, 701437, 701438, 701439, 701440, 701441, 701443, 701444, 701445, 701446, 701448, 701450, 701452, 701453, 701454, 701455, 701456, 701457, 701458, 701459, 701460, 701461, 701462, 701463, 701464, 701465, 701466, 701467, 701468, 701469, 701470, 701471, 701473, 701474, 701475, 701476, 701478, 701479, 701480, 701481, 701482, 701483, 701484, 701487, 701488, 701489, 701490, 701491, 701492, 701493, 701494, 701495, 701496, 701497, 701499, 701500, 701501, 701502, 701503, 701505, 701506, 701507, 701508, 701509, 701510, 701511, 701512, 701513, 701515, 701516, 701518, 701521, 701522, 701523, 701524, 701525, 701526, 701527, 701528, 701530, 701532, 701533, 701534, 701535, 701536, 701537, 701538, 701540, 701541, 701542, 701543, 701544, 701546, 701547, 701548, 701549, 701550, 701551, 701552, 701553, 701554, 701555, 701556, 701557, 701558, 702382, 702397, 702399, 702401, 702415, 702421, 702437, 702442, 702443, 702444, 702454, 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704046, 704049, 704053, 704057, 704062, 704063, 704065, 704066, 704068, 704070, 704079, 704081, 704082, 704083, 704084, 704086, 705127, 705129, 705131, 705133, 705135, 705138, 705139, 707293, 707294, 707298, 707316, 707326, 707327, 707329, 707336, 707339, 707342, 707344, 707346, 707349, 707354, 707356, 707362, 707366, 707378, 707380, 707382, 707386, 707388, 707390, 707392, 707393, 707395, 707396, 707397, 707400, 707401, 707403, 707404, 707405, 707406, 707407, 707408, 707411, 707425, 707426, 707427, 707429, 707431, 707433, 707434, 707436, 707437, 707439, 707440, 707441, 707453, 707463, 707464, 707465, 707466, 707467, 707469, 707474, 707482, 707487, 707489, 707492, 707501, 707506, 707507, 707509, 707515, 707516, 707521, 707523, 707525, 707533, 707534, 707539, 707542, 707543, 707544, 707545, 707548, 707550, 707551, 707553, 707554, 707558, 707559, 707560, 707562, 707567, 707568, 707569, 707570, 707572, 707574, 707576, 707577, 707578, 707579, 707580, 707581, 707583, 707584, 707586, 707589… Full codes in the FDA record	5920 units

Based on the official FDA remedy

What to do — step by step

1
Ensure that the medical device is used by trained healthcare professionals.
2
Follow the manufacturer's instructions for proper use and maintenance.
3
Report any adverse events or complications to the appropriate regulatory body.

How this recall unfolded

Recall timeline

FDA published this recall 41 days after the firm started it.

Jun 3, 2021Firm started the recall
Jul 2, 2021FDA classified it Class II
Jul 14, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How do I report a problem with a Boston Scientific product?

If you experience any adverse events or complications, report them to the appropriate regulatory body, such as the FDA in the United States or the relevant health authority in your country.

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Link to this recall

<a href="https://govinfonow.com/recall/62397-boston-scientific-medical-devices-surgical-tools-and-implants">Boston Scientific - Medical Devices, Surgical Tools, and Implants (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2000-2021 (June 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2000-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.