Use caution Medical device recall · FDA · Published June 3, 2021
Boston Scientific INLIVEN CRT-P pacemakers: Risk of system resets due to battery issues
Boston Scientific recalls specific INLIVEN CRT-P pacemakers (models V284, V285, W274, W275) with Extended Life batteries that may initiate Safety Mode, causing temporary system resets. Replacement is required.
Use caution until it’s fixed
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
Contact the company
Recalling firmBoston Scientific Corporation4100 Hamline Ave N Bldg 3 · Saint Paul, MN 55112-5700
What happened, in plain English
Boston Scientific is recalling specific INLIVEN CRT-P pacemakers (models V284, V285, W274, W275) with Extended Life batteries. These devices may enter Safety Mode later in their life, causing temporary system resets. Replacement is required to prevent potential therapy interruptions. Read more at govinfonow.com/recall/62404-boston-scientific-inliven-crt-p-pacemakers-risk-of-system-resets.
Source Summary by GovInfoNow · govinfonow.com/recall/62404-boston-scientific-inliven-crt-p-pacemakers-risk-of-system-resets · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2020-2021
Cite this page
“Boston Scientific INLIVEN CRT-P pacemakers: Risk of system resets due to battery issues.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62404-boston-scientific-inliven-crt-p-pacemakers-risk-of-system-resets. Based on FDA recall #Z-2020-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2020-2021%22&limit=1).
Why it’s dangerous
The device's battery may develop high internal impedance over time, causing temporary high-power consumption during telemetry attempts. This can trigger system resets to Safety Mode, which temporarily stops therapy delivery. Replacement is required to maintain proper function.
Who’s affected
Patients with the recalled INLIVEN CRT-P pacemakers (models V284, V285, W274, W275) using Extended Life batteries are affected. Those with the specific serial numbers listed in the recall are at risk.
How to tell if you have this one
Check your device model (V284, V285, W274, or W275) and Extended Life battery. The recall includes specific serial numbers listed in the official notice. If your device matches these details, it is affected.
- Brand
Boston Scientific- Category
Medical device
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 I- Status
Ongoing- Distribution
Worldwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2015-2021 | ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021); a) J064, Serial Numbers: 390022, 390405, 100027, 100085, 100096, 100127, 100182, 100228, 100248, 100267, 100449, 100491, 100495, 100543, 100575, 100634, 100651, 100659, 100704, 100707, 100741, 100789, 100806, 100907, 100961, 101002, 101003, 101061, 101160, 101166, 101183, 101208, 101253, 101255, 101344, 101415, 101416, 101421, 101438, 101445, 101448, 101450, 101452, 101459, 101693, 101721, 101850, 102002, 102003, 102017, 102018, 102020, 102030, 102144, 102180, 102295, 102297, 102333, 102348, 102350, 102353, 102366, 102368, 102369, 102381, 102425, 102440, 102458, 102474, 102482, 102590, 102594, 102596, 102600, 102602, 102603, 102604, 102612, 102615, 102616, 102617, 102618, 102752, 102753, 102801, 102819, 102842, 102894, 102896, 102924, 102962, 102966, 102973, 102976, 103000, 103002, 103004, 103013, 103014, 103015, 103021, 103027, 103042, 103043, 103046, 103075, 103081, 103084, 103089, 103095, 103117, 103121, 103128, 103147, 103157, 103160, 103169, 103177, 103187, 103194, 103199, 103203, 103205, 103216, 103217, 103218, 103221, 103229, 103234, 103239, 103248, 103253, 103257, 103259, 103263, 103269, 103270, 103274, 103293, 103297, 103312, 103334, 103345, 103352, 103357, 103360, 103361, 103368, 103372, 103381, 103382, 103384, 103385, 103386, 103387, 103393, 103398, 103445, 103471, 103475, 103480, 103490, 103500, 103502, 103509, 103512, 103515, 103525, 103526, 103538, 103564, 103601, 103622, 103626, 103627, 103629, 103634, 103639, 103641, 103642, 103643, 103645, 103648, 103649, 103651, 103655, 103656, 103657, 103658, 103670, 103672, 103673, 103674, 103675, 103676, 103678, 103681, 103682, 103685, 103686, 103690, 103693, 103694, 103702, 103710, 103712, 103720, 103727, 103728, 103731, 103734, 103738, 103741, 103743, 103744, 103746, 103747, 103748, 103757, 103758, 103759, 103760, 103762, 103763, 103768, 103770, 103783, 103784, 103785, 103788, 103790, 103796, 103801, 103808, 103810, 103814, 103815, 103819, 103826, 103831, 103833, 103838, 103839, 103880, 103893, 103896, 103897, 103898, 103900, 103902, 103903, 103904, 103905, 103908, 103910, 103912, 103919, 103924, 103925, 103926, 103929, 103931, 103933, 103934, 103947, 103948, 103958, 103962, 103964, 103966, 103967, 103979, 103981, 103982, 103984, 103996, 104011, 104061, 104085, 104108, 104132, 104133, 250073, 250075, 250076, 250077, 250079, 250080, 389621, 389624, 389625, 389628, 389629, 389630, 389631, 389633, 389634, 389636, 389638, 389642, 389648, 389653, 389655, 389657, 389658, 389659, 389661, 389662, 389663, 389664, 389666, 389669, 389671, 389675, 389677, 389690, 389691, 389693, 389698, 389699, 389700, 389705, 389721, 389723, 389726, 389728, 389729, 389730, 389738, 389742, 389743, 389746, 389747, 389748, 389749, 389752, 389757, 389759, 389760, 389763, 389766, 389768, 389770, 389773, 389777, 389778, 389780, 389782, 389784, 389791, 389792, 389793, 389798, 389799, 389801, 389804, 389805, 389807, 389808, 389809, 389811, 389813, 389815, 389816, 389818, 389828, 389829, 389830, 389831, 389840, 389844, 389851, 389856, 389861, 389875, 389891, 389897, 389900, 389901, 389902, 389906, 389907, 389909, 389911, 389915, 389919, 389927, 389929, 389930, 389931, 389937, 389938, 389940, 389941, 389942, 389945, 389948, 389952, 389953, 389954, 389956, 389958, 389962, 389964, 389965, 389967, 389969, 389970, 389973, 389974, 389976, 389978, 389979, 389980, 389981, 389982, 389983, 389985, 389986, 389987, 389990, 389993, 389996, 389998, 390000, 390002, 390003, 390004, 390005, 390009, 390013, 390015, 390016, 390018, 390020, 390022, 390023, 390028, 390031, 390033, 390039, 390056, 390058, 390061, 390078, 390081, 390084, 390087, 390133, 390134, 390136, 390137, 390139, 390140, 390141, 390143, 390145, 390146, 390148, 390149, 390150, 390151, 390152, 390156, 390158, 390163, 390167, 390171, 390172, 390174, 390175, 390178, 390179, 390180, 390181, 390184, 390185, 390190, 390191, 390196, 390201, 390202, 390203, 390206, 390208, 390209, 390210, 390211, 390212, 390213, 390215, 390217, 390218, 390219, 390220, 390225, 390226, 390228, 390230, 390231, 390237, 390238, 390242, 390271, 390275, 390288, 390292, 390293, 390296, 390300, 390306, 390310, 390312, 390313, 390314, 390315, 390316, 390318, 390320, 390322, 390323, 390324, 390326, 390328, 390329, 390330, 390333, 390334, 390345, 390348, 390352, 390362, 390364, 390365, 390372, 390373, 390376, 390377, 390378, 390381, 390391, 390393, 390397, 390398, 390400, 390401, 390404, 390405, 390408, 390414, 390416, 390417, 390418, 390420, 390422, 390425, 390427, 390428, 390429, 390431, 390432, 390434, 390435, 390437, 390439, 390440, 390441, 390442, 390443, 390445, 390446, 390448, 390450, 390452, 390453, 390454, 390456, 390457, 390458, 390459, 390460, 390461, 390462, 390463, 390465, 390466, 390467, 390468, 390469, 390470, 390471, 390472, 390473, 390474, 390475, 390480, 390483, 390487, 390489, 390493, 390496, 390498, 390503, 390504, 390505, 390506, 390508, 390515, 390517, 390519, 390521, 390526, 390529, 390531, 390534, 390535, 390538, 390540, 390542, 390543, 390544, 390546, 390549, 390550, 390552, 390556, 390560, 390565, 390566, 390571, 390572, 390573, 390578, 390579, 390580, 390596, 390597, 390602, 390604, 390605, 390607, 390608, 390609, 390610, 390611, 390617, 390618, 390619, 390620, 390621, 390622, 390623, 390624, 390625, 390627, 390628, 390631, 390635, 390636, 390640, 390642, 390645, 390647, 390649, 390650, 390655, 390656, 390657, 390661, 390663, 390664, 390665, 390666, 390667, 390671, 390672, 390673, 390674, 390675, 390676, 390677, 390678, 390679, 390680, 390681, 390682, 390683, 390684, 390685, 390686, 390687, 390688, 390689, 390690, 390691, 390692, 390693, 390694, 390695, 390696, 390697, 390698, 390699, 390700, 390701, 390702, 390703, 390704, 390705, 390706, 390720, 390726, 390727, 390735, 390736, 390737, 390740, 390741, 390773, 390777, 390826, 390833, 390885, 390925, 391003, 391270, 391447, 391470, 391585, 391631, 391739, 391750, 391791, 391924, 392154, 392159, 392207, 392362, 392405, 392444, 392464, 392476, 392522, 392652, 392680, 392684, 392694, 392745, 392802, 392872, 392912, 100001, 100002, 100003, 100004, 100005, 100006, 100007, 100009, 100010, 100011, 100012, 100013, 100014, 100016, 100017, 100018, 100019, 100020, 100021, 100022, 100023, 100025, 100028, 100029, 100030, 100031, 100032, 100034, 100035, 100036, 100037, 100038, 100039, 100040, 100041, 100042, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100054, 100055, 100056, 100057, 100058, 100059, 100060, 100061, 100063, 100064, 100065, 100066, 100067, 100068, 100069, 100070, 100071, 100072, 100073, 100074, 100075, 100076, 100078, 100079, 100080, 100081, 100082, 100083, 100084, 100086, 100087, 100088, 100089, 100090, 100091, 100092, 100094, 100095, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100128, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100143, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100154, 100156, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100183, 100184, 100185, 100186, 100187, 100188, 100189, 100191, 100192, 100193, 100194, 100195, 100196, 100197, 100198, 100199, 100200, 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100208, 100209, 100210, 100211, 100212, 100213, 100215, 100216, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100229, 100230, 100231, 100232, 100233, 100236, 100238, 100239, 100241, 100242, 100244, 100245, 100246, 100247, 100249, 100250, 100251, 100252, 100253, 100254, 100256, 100257, 100258, 100259, 100260, 100261, 100262, 100263, 100264, 100265, 100266, 100268, 100269, 100270, 100271, 100272, 100273, 100274, 100275, 100276, 100277, 100278, 100279, 100280, 100281, 100282, 100283, 100284, 100285, 100286, 100287, 100288, 100289, 100290, 100291, 100292, 100293, 100294, 100295, 100296, 100297, 100298, 100299, 100300, 100301, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100310, 100311, 100312, 100313, 100314, 100315, 100316, 100317, 100318, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100328, 100329, 100330, 100331, 100332, 100333, 100334, 100335, 100336, 100337, 100338, 100339, 100340, 100341, 100342, 100343, 100344, 100345, 100346, 100347, 100348, 100349, 100350, 100351, 100352, 100353, 100354, 100355, 100356, 100357, 100358, 100359, 100363, 100364, 100365, 100366, 100367, 100368, 100369, 100370, 100371, 100372, 100373, 100374, 100375, 100376, 100377, 100378, 100379, 100380, 100381, 100382, 100383, 100384, 100385, 100386, 100387, 100388, 100389, 100390, 100391, 100392, 100393, 100394, 100395, 100396, 100397, 100398, 100399, 100400, 100401, 100402, 100403, 100404, 100405, 100406, 100407, 100408, 100409, 100410, 100411, 100412, 100413, 100414, 100415, 100416, 100417, 100418, 100420, 100421, 100422, 100423, 100424, 100425, 100426, 100427, 100428, 100429, 100430, 100431, 100432, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100448, 100450, 100451, 100452, 100453, 100454, 100455, 100456, 100457, 100458, 100459, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100469, 100470, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100483, 100484, 100485, 100486, 100487, 100488, 100489, 100490, 100492, 100493, 100494, 100496, 100497, 100498, 100499, 100500, 100501, 100503, 100504, 100505, 100506, 100507, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100520, 100521, 100523, 100525, 100526, 100528, 100529, 100530, 100531, 100532, 100533, 100534, 100535, 100536, 100537, 100538, 100539, 100540, 100541, 100542, 100544, 100545, 100547, 100548, 100549, 100550, 100551, 100552, 100553, 100554, 100556, 100557, 100558, 100559, 100560, 100562, 100563, 100564, 100565, 100567, 100568, 100569, 100570, 100571, 100572, 100573, 100574, 100576, 100577, 100578, 100579, 100580, 100581, 100582, 100583, 100584, 100585, 100586, 100587, 100588, 100589, 100590, 100591, 100592, 100593, 100595, 100596, 100597, 100598, 100599, 100600, 100601, 100602, 100603, 100604, 100605, 100606, 100607, 100608, 100609, 100610, 100611, 100612, 100613, 100615, 100616, 100617, 100618, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100626, 100627, 100628, 100629, 100630, 100631, 100632, 100633, 100635, 100636, 100637, 100638, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100647, 100648, 100649, 100652, 100653, 100654, 100655, 100656, 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100794, 100795… Full codes in the FDA record | 15,717 units |
| Z-2016-2021 | INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021); a) J174, Serial Numbers: 100017, 100107, 100122, 100124, 100174, 100278, 100284, 100374, 100377, 100430, 100596, 100636, 100685, 100725, 101002, 101103, 101241, 101331, 101348, 101410, 101413, 101442, 101627, 101648, 101682, 101753, 101964, 101981, 101982, 102019, 102043, 102156, 102160, 102261, 102262, 102331, 102333, 102370, 102376, 102476, 102482, 102717, 102813, 102826, 102838, 102908, 103055, 103071, 103086, 103127, 103146, 103198, 103209, 103212, 103218, 103245, 103248, 103291, 103296, 103330, 103414, 103489, 103529, 103600, 103710, 103753, 103812, 103842, 103865, 103985, 104045, 104059, 104075, 104079, 104120, 104138, 104205, 104211, 104291, 104318, 104346, 104353, 104386, 104391, 104399, 104483, 104558, 104690, 104803, 104877, 104881, 104883, 104898, 104901, 104922, 104933, 104958, 104982, 105010, 105023, 105086, 105144, 105147, 105157, 105163, 105169, 105170, 105178, 105225, 105237, 105240, 105314, 105335, 105360, 105389, 105400, 105402, 105430, 105441, 105444, 105446, 105469, 105599, 105619, 105629, 105762, 105823, 105842, 105902, 105904, 105970, 105973, 105976, 105977, 105996, 106012, 106053, 106065, 106145, 106172, 106244, 106299, 106334, 106384, 106394, 106410, 106430, 106437, 106448, 106452, 106485, 106490, 106506, 106507, 106509, 106519, 106525, 106538, 106627, 106715, 106717, 106718, 106791, 106934, 106972, 106981, 107302, 107374, 107503, 107599, 107614, 107628, 107632, 107702, 107717, 107769, 107774, 107782, 107823, 107833, 107862, 107969, 108015, 108097, 108101, 108105, 108116, 108121, 108131, 108133, 108144, 108154, 108185, 108221, 108237, 108240, 108242, 108256, 108276, 108321, 108368, 108391, 108428, 108462, 108465, 108467, 108479, 108499, 108505, 108513, 108546, 108590, 108591, 108610, 108617, 108624, 108634, 108665, 108678, 108683, 108689, 108699, 108700, 108704, 108730, 108736, 108809, 108826, 108828, 108844, 108847, 108904, 108920, 108924, 108960, 108961, 108966, 108975, 108983, 108994, 109010, 109017, 109045, 109062, 109073, 109078, 109079, 109082, 109085, 109096, 109109, 109118, 109131, 109138, 109146, 109175, 109183, 109188, 109215, 109232, 109240, 109245, 109248, 109251, 109258, 109259, 109274, 109285, 109288, 109305, 109333, 109344, 109345, 109357, 109362, 109363, 109365, 109366, 109371, 109376, 109387, 109406, 109420, 109443, 109461, 109482, 109495, 109499, 109503, 109518, 109525, 109527, 109548, 109583, 109617, 109624, 109633, 109635, 109637, 109642, 109644, 109649, 109651, 109654, 109659, 109660, 109663, 109664, 109678, 109685, 109686, 109687, 109689, 109690, 109691, 109693, 109694, 109695, 109696, 109699, 109725, 109739, 109756, 109798, 109820, 109826, 109862, 109876, 109880, 109883, 109892, 109896, 109904, 109945, 109977, 109981, 109982, 109992, 110028, 110112, 110123, 110153, 110169, 110232, 110285, 110300, 110348, 110385, 110403, 110492, 110509, 110544, 110620, 110626, 110657, 110702, 110716, 411920, 411923, 411942, 509334, 509340, 509341, 509344, 509351, 509352, 509362, 509370, 509373, 509387, 509392, 509396, 509406, 509412, 509417, 509425, 509428, 509430, 509434, 509446, 509447, 509460, 509461, 509473, 509480, 509507, 509512, 509528, 509531, 509536, 509550, 509562, 509563, 509564, 509565, 509570, 509571, 509572, 509575, 509578, 509581, 509588, 509589, 509600, 509620, 509644, 509647, 509653, 509667, 509698, 509706, 509708, 509737, 509738, 509745, 509752, 509754, 509759, 509764, 509766, 509770, 509776, 509777, 509778, 509784, 509789, 509790, 509796, 509808, 509810, 509814, 509838, 509846, 509854, 509864, 509874, 509882, 509905, 509909, 509913, 509922, 509941, 509942, 509943, 509960, 509972, 509982, 509991, 509994, 510001, 510024, 510027, 510035, 510044, 510045, 510052, 510054, 510068, 510076, 510077, 510083, 510084, 510089, 510090, 510092, 510094, 510114, 510125, 510129, 510133, 510136, 510139, 510151, 510155, 510167, 510176, 510177, 510179, 510181, 510183, 510188, 510190, 510192, 510206, 510209, 510265, 510286, 510295, 510303, 510307, 510310, 510314, 510322, 510326, 510329, 510335, 510336, 510337, 510343, 510347, 510350, 510354, 510425, 510435, 510448, 510456, 510470, 510483, 510490, 510495, 510497, 510522, 510528, 510530, 510532, 510535, 510556, 510558, 510563, 510568, 510570, 510586, 510590, 510599, 510601, 510617, 510632, 510638, 510640, 510641, 510642, 510643, 510646, 510647, 510652, 510660, 510667, 510669, 510678, 510681, 510719, 510726, 510736, 510747, 510792, 510800, 510801, 510802, 510803, 510804, 510805, 510806, 510807, 510808, 510810, 510811, 510812, 510814, 510820, 510845, 510846, 510847, 510848, 510849, 510850, 510853, 510854, 510855, 510861, 510862, 510866, 510867, 510870, 510872, 510873, 510874, 510876, 510877, 510879, 510884, 510885, 510887, 510888, 510889, 510891, 510892, 510893, 510898, 510899, 510902, 510905, 510906, 510908, 510910, 510912, 510914, 510915, 510916, 510918, 510919, 510920, 510924, 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511287, 511289, 511290, 511291, 511293, 511294, 511295, 511296, 511298, 511299, 511300, 511302, 511303, 511305, 511307, 511308, 511309, 511311, 511312, 511314, 511315, 511316, 511317, 511318, 511319, 511320, 511321, 511322, 511323, 511324, 511326, 511329, 511330, 511335, 511338, 511339, 511340, 511341, 511342, 511345, 511347, 511348, 511349, 511360, 511365, 511367, 511369, 511485, 511487, 511573, 511574, 511575, 511576, 511577, 511578, 511579, 511580, 511581, 511582, 511585, 511650, 511670, 511676, 511678, 511684, 511688, 511690, 511696, 511697, 511708, 511714, 511728, 511738, 511739, 511740, 511741, 511743, 511744, 511745, 511746, 511867, 511951, 511986, 511992, 512000, 512016, 512023, 512036, 512041, 512063, 512096, 512108, 512221, 512260, 512281, 512310, 512391, 512421, 512497, 512535, 512567, 512588, 512670, 512706, 512723, 512867, 512923, 513211, 513448, 513575, 513687, 513781, 513815, 513992, 514081, 514238, 514255, 514378, 514412, 514433, 514544, 514550, 514609, 514658, 100001, 100002, 100003, 100004, 100005, 100006, 100007, 100008, 100009, 100011, 100012, 100013, 100014, 100015, 100016, 100020, 100021, 100023, 100024, 100025, 100026, 100027, 100028, 100029, 100030, 100033, 100036, 100037, 100039, 100040, 100041, 100043, 100044, 100045, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100059, 100060, 100063, 100064, 100065, 100066, 100067, 100068, 100070, 100074, 100075, 100076, 100078, 100079, 100080, 100082, 100084, 100087, 100088, 100091, 100092, 100094, 100095, 100096, 100097, 100098, 100099, 100100, 100101, 100102, 100103, 100104, 100105, 100106, 100108, 100109, 100110, 100111, 100112, 100113, 100114, 100115, 100116, 100118, 100119, 100120, 100121, 100123, 100125, 100126, 100127, 100128, 100130, 100131, 100132, 100133, 100134, 100135, 100136, 100137, 100138, 100139, 100140, 100141, 100142, 100143, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100154, 100156, 100157, 100158, 100159, 100160, 100161, 100162, 100163, 100164, 100165, 100166, 100167, 100168, 100169, 100170, 100171, 100172, 100175, 100176, 100177, 100178, 100179, 100180, 100181, 100182, 100183, 100184, 100185, 100186, 100187, 100188, 100189, 100190, 100191, 100192, 100193, 100194, 100195, 100196, 100197, 100198, 100199, 100200, 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100208, 100209, 100211, 100212, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100227, 100228, 100229, 100230, 100231, 100232, 100233, 100234, 100235, 100236, 100237, 100238, 100239, 100240, 100241, 100242, 100243, 100244, 100245, 100246, 100247, 100248, 100249, 100250, 100251, 100252, 100253, 100254, 100255, 100256, 100257, 100258, 100259, 100260, 100261, 100262, 100263, 100264, 100265, 100266, 100267, 100268, 100269, 100270, 100271, 100272, 100273, 100274, 100275, 100276, 100277, 100279, 100280, 100281, 100282, 100283, 100285, 100286, 100287, 100288, 100289, 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100423, 100424, 100425, 100426, 100427, 100428, 100429, 100431, 100433, 100434, 100435, 100436, 100437, 100438, 100439, 100440, 100441, 100442, 100443, 100444, 100445, 100446, 100447, 100450, 100451, 100452, 100453, 100454, 100455, 100457, 100458, 100459, 100460, 100461, 100462, 100463, 100464, 100465, 100466, 100467, 100468, 100469, 100470, 100471, 100472, 100473, 100474, 100475, 100476, 100477, 100478, 100479, 100480, 100481, 100482, 100483, 100484, 100485, 100486, 100488, 100489, 100490, 100491, 100492, 100493, 100494, 100495, 100496, 100497, 100498, 100499, 100500, 100501, 100502, 100503, 100504, 100505, 100506, 100507, 100508, 100509, 100510, 100511, 100513, 100514, 100515, 100516, 100517, 100518, 100519, 100520, 100521, 100522, 100523, 100524, 100525, 100526, 100527, 100528, 100529, 100530, 100531, 100532, 100533, 100534, 100535, 100536, 100537, 100538, 100539, 100540, 100541, 100542, 100543, 100544, 100545, 100546, 100547, 100549, 100550, 100551, 100552, 100553, 100554, 100555, 100556, 100557, 100558, 100559, 100560, 100561, 100562, 100563, 100564, 100565, 100566, 100567, 100568, 100569, 100570, 100571, 100572, 100573, 100574, 100575, 100576, 100577, 100578, 100579, 100580, 100581, 100582, 100583, 100584, 100585, 100586, 100587, 100588, 100589, 100590, 100591, 100592, 100593, 100594, 100595, 100597, 100598, 100599, 100600, 100601, 100602, 100603, 100604, 100605, 100606, 100607, 100608, 100610, 100611, 100612, 100614, 100615, 100616, 100619, 100620, 100621, 100622, 100623, 100624, 100625, 100626, 100628, 100629, 100630, 100632, 100633, 100634, 100637, 100638, 100639, 100640, 100641, 100642, 100644, 100646, 100647, 100648, 100649, 100650, 100652, 100653, 100654, 100655, 100656, 100657, 100658, 100659, 100660, 100662, 100663, 100665, 100666, 100667, 100668, 100670, 100671, 100672, 100673, 100674, 100675, 100676, 100677, 100678, 100679, 100680, 100681, 100683, 100684, 100686, 100687, 100689, 100690, 100691, 100693, 100694, 100696, 100697, 100698, 100699, 100700, 100701, 100702… Full codes in the FDA record | 40,224 units |
| Z-2017-2021 | VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021); a) J274, Serial Numbers: 100000, 100001, 100005, 100008, 100009, 100010, 100016, 100017, 100019, 100021, 100026, 100028, 100031, 100032, 100033, 100034, 100036, 100037, 100038, 100041, 100042, 100044, 100045, 100046, 100047, 100049, 100051, 100052, 100055, 100056, 100057, 100060, 100062, 100075, 100084, 100088, 100095, 100098, 100100, 100101, 100102, 100103, 100106, 100107, 100109, 100112, 100114, 100115, 100116, 100118, 100120, 100121, 395016, 100012, 100013, 100018, 100020, 100029, 100030, 100043, 100054, 100065, 100105, 100117, 394733, 394736, 394741, 394742, 394743, 394745, 394746, 394747, 394748, 394749, 394750, 394751, 394752, 394753, 394754, 394755, 394756, 394757, 394758, 394759, 394762, 394763, 394764, 394765, 394766, 394767, 394768, 394769, 394770, 394771, 394772, 394773, 394774, 394775, 394776, 394777, 394778, 394779, 394780, 394781, 394782, 394783, 394784, 394785, 394786, 394787, 394788, 394789, 394790, 394791, 394792, 394793, 394794, 394795, 394796, 394797, 394798, 394799, 394800, 394801, 394802, 394803, 394804, 394805, 394806, 394807, 394808, 394809, 394810, 394811, 394812, 394813, 394814, 394815, 394816, 394817, 394818, 394819, 394820, 394821, 394825, 394826, 394827, 394828, 394829, 394830, 394831, 394832, 394833, 394834, 394835, 394836, 394837, 394838, 394839, 394840, 394841, 394842, 394843, 394844, 394845, 394846, 394847, 394848, 394849, 394850, 394851, 394852, 394853, 394854, 394855, 394856, 394857, 394858, 394859, 394860, 394861, 394862, 394863, 394864, 394865, 394866, 394867, 394868, 394869, 394870, 394871, 394874, 394875, 394876, 394877, 394878, 394879, 394880, 394882, 394883, 394884, 394885, 394886, 394887, 394888, 394890, 394891, 394892, 394893, 394894, 394895, 394896, 394897, 394898, 394899, 394900, 394901, 394902, 394903, 394905, 394906, 394907, 394908, 394909, 394910, 394911, 394912, 394915, 394916, 394917, 394918, 394919, 394920, 394921, 394922, 394923, 394924, 394925, 394926, 394927, 394928, 394929, 394931, 394932, 394933, 394934, 394935, 394936, 394937, 394938, 394939, 394940, 394941, 394942, 394943, 394944, 394945, 394946, 394947, 394948, 394949, 394950, 394951, 394952, 394953, 394954, 394955, 394956, 394957, 394958, 394959, 394960, 394961, 394962, 394963, 394964, 394965, 394966, 394967, 394968, 394969, 394970, 394971, 394972, 394973, 394974, 394975, 394976, 394977, 394978, 394979, 394980, 394981, 394982, 394983, 394984, 394985, 394986, 394987, 394988, 394989, 394990, 394991, 394992, 394993, 394994, 394995, 394996, 394997, 394998, 394999, 395000, 395001, 395002, 395003, 395004, 395005, 395006, 395007, 395008, 395009, 395010, 395011, 395013, 395014, 395017, 395018, 395019, 395020, 395022, 395023, 395024, 395025, 395026, 395027, 395028, 395029, 395030, 395031, 395032, 395033, 395034, 395035, 395036, 395037, 395038, 395039, 395040, 395041 b) J277, Serial Numbers: 101302, 104161, 100001, 100002, 100003, 100005, 100007, 100009, 100010, 100011, 100012, 100013, 100014, 100015, 100016, 100020, 100021, 100022, 100024, 100025, 100027, 100028, 100029, 100030, 100031, 100033, 100034, 100035, 100037, 100039, 100040, 100041, 100042, 100044, 100045, 100047, 100049, 100051, 100052, 100057, 100061, 100062, 100071, 100108, 100111, 100130, 100143, 100158, 100240, 100248, 100277, 100313, 100330, 100417, 100421, 100427, 100445, 100450, 100452, 100457, 100475, 100486, 100494, 100516, 100553, 100555, 100563, 100576, 100611, 100686, 100736, 100749, 100779, 100780, 100807, 100839, 100864, 100886, 100916, 100923, 100964, 100969, 100983, 100988, 101018, 101042, 101062, 101073, 101093, 101122, 101157, 101302, 101305, 101322, 101420, 101437, 101452, 101502, 101672, 101766, 101793, 101797, 101915, 101929, 102052, 102080, 102137, 102218, 102276, 102310, 102315, 102335, 102368, 102395, 102428, 102475, 102496, 102506, 102526, 102542, 102553, 102554, 102573, 102576, 102589, 102606, 102647, 102653, 102654, 102672, 102703, 102710, 102767, 102793, 102805, 102842, 102853, 102961, 103001, 103029, 103032, 103159, 103221, 103235, 103259, 103391, 103410, 103483, 103506, 103531, 103551, 103743, 103758, 103820, 103838, 103890, 103930, 104056, 104058, 104090, 104161, 104187, 104246, 104358, 104422, 104487, 104502, 104796, 104798, 104802, 104855, 104872, 104957, 104985, 105136, 105167, 105234, 431078, 431204, 431361, 431408, 431427, 431438, 431482, 431505, 431506, 431550, 431599, 431717, 431749, 431962, 432068, 432161, 432171, 432210, 432250, 432425, 432446, 432569, 432590, 432693, 432878, 432907, 432916, 432986, 433029, 433058, 433075, 433247, 433258, 433268, 433288, 433301, 433376, 433436, 433447, 433448, 433450, 433452, 433453, 433454, 433455, 433456, 433457, 433458, 433460, 433462, 433464, 433469, 433479, 433489, 100070, 100072, 100073, 100074, 100075, 100076, 100078, 100079, 100080, 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, 100109, 100110, 100112, 100113, 100114, 100116, 100117, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100126, 100127, 100131, 100132, 100133, 100135, 100136, 100137, 100138, 100139, 100140, 100142, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100154, 100155, 100156, 100157, 100160, 100161, 100162, 100163, 100164, 100165, 100167, 100168, 100169, 100170, 100171, 100172, 100173, 100174, 100176, 100177, 100178, 100180, 100181, 100182, 100183, 100184, 100185, 100186, 100187, 100188, 100189, 100191, 100192, 100193, 100194, 100195, 100197, 100198, 100200, 100201, 100202, 100203, 100204, 100205, 100206, 100207, 100208, 100211, 100212, 100213, 100214, 100215, 100216, 100217, 100218, 100219, 100220, 100221, 100222, 100223, 100224, 100225, 100226, 100227, 100228, 100229, 100230, 100231, 100232, 100233, 100234, 100235, 100236, 100238, 100239, 100241, 100242, 100243, 100244, 100245, 100247, 100250, 100251, 100252, 100253, 100254, 100255, 100256, 100257, 100258, 100259, 100260, 100261, 100262, 100263, 100264, 100265, 100266, 100268, 100269, 100270, 100271, 100272, 100273, 100274, 100275, 100276, 100278, 100279, 100280, 100281, 100283, 100284, 100285, 100286, 100288, 100289, 100290, 100291, 100292, 100293, 100294, 100295, 100296, 100297, 100298, 100299, 100300, 100301, 100302, 100303, 100304, 100305, 100306, 100307, 100308, 100309, 100311, 100312, 100314, 100315, 100316, 100317, 100318, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100329, 100331, 100332, 100333, 100334, 100335, 100336, 100337, 100338, 100339, 100340, 100341, 100342, 100343, 100344, 100345, 100346, 100347, 100348, 100349, 100350, 100351, 100352, 100353, 100354, 100356, 100357, 100358, 100359, 100360, 100361, 100362, 100363, 100364, 100365, 100366, 100367, 100368, 100369, 100371, 100372, 100373, 100374, 100376, 100377, 100378, 100380, 100381, 100382, 100383, 100384, 100385, 100386, 100387, 100388, 100389, 100390, 100391, 100392, 100393, 100395, 100396, 100397, 100398, 100400, 100401, 100402, 100404, 100405, 100406, 100407, 100408, 100409, 100412, 100413, 100414, 100415, 100416, 100418, 100419, 100420, 100422, 100423, 100424, 100425, 100426, 100428, 100429, 100430, 100431, 100432, 100433, 100434, 100435, 100437, 100438, 100440, 100441, 100442, 100443, 100444, 100446, 100447, 100448, 100449, 100453, 100454, 100455, 100456, 100458, 100460, 100461, 100462, 100463, 100464, 100466, 100467, 100468, 100470, 100471, 100474, 100477, 100478, 100479, 100481, 100482, 100483, 100487, 100490, 100492, 100493, 100495, 100496, 100497, 100500, 100501, 100502, 100503, 100504, 100507, 100508, 100509, 100510, 100511, 100512, 100513, 100514, 100515, 100517, 100518, 100519, 100520, 100521, 100522, 100523, 100524, 100525, 100526, 100527, 100528, 100529, 100530, 100531, 100532, 100533, 100534, 100535, 100536, 100537, 100538, 100539, 100541, 100543, 100544, 100545, 100546, 100547, 100548, 100549, 100550, 100551, 100552, 100554, 100556, 100557, 100558, 100559, 100560, 100561, 100562, 100564, 100565, 100566, 100567, 100568, 100569, 100570, 100572, 100573, 100574, 100577, 100578, 100579, 100580, 100581, 100582, 100584, 100585, 100586, 100587, 100588, 100589, 100590, 100591, 100592, 100593, 100594, 100595, 100596, 100597, 100598, 100599, 100600, 100601, 100602, 100603, 100604, 100605, 100606, 100607, 100608, 100609, 100610, 100612, 100613, 100614, 100615, 100616, 100617, 100618, 100621, 100622, 100623, 100624, 100626, 100627, 100628, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100636, 100637, 100638, 100639, 100640, 100641, 100642, 100643, 100644, 100645, 100646, 100647, 100648, 100649, 100650, 100652, 100653, 100654, 100655, 100656, 100657, 100659, 100661, 100662, 100663, 100664, 100665, 100666, 100667, 100668, 100669, 100670, 100671, 100672, 100673, 100674, 100676, 100677, 100678, 100679, 100680, 100681, 100683, 100684, 100685, 100687, 100688, 100689, 100690, 100691, 100693, 100694, 100695, 100696, 100697, 100699, 100700, 100701, 100702, 100704, 100706, 100707, 100708, 100709, 100710, 100711, 100712, 100713, 100714, 100715, 100716, 100717, 100718, 100719, 100720, 100721, 100722, 100723, 100724, 100725, 100726, 100727, 100728, 100729, 100730, 100731, 100732, 100733, 100734, 100735, 100737, 100738, 100739, 100740, 100741, 100742, 100743, 100744, 100745, 100746, 100747, 100748, 100750, 100751, 100752, 100753, 100754, 100755, 100756, 100757, 100758, 100759, 100760, 100761, 100762, 100763, 100764, 100765, 100766, 100767, 100768, 100769, 100770, 100771, 100772, 100773, 100774, 100775, 100776, 100777, 100778, 100782, 100783, 100784, 100785, 100786, 100787, 100789, 100791, 100792, 100793, 100794, 100795, 100796, 100797, 100798, 100799, 100800, 100801, 100803, 100804, 100805, 100808, 100809, 100811, 100812, 100813, 100814, 100816, 100817, 100819, 100820, 100821, 100822, 100823, 100824, 100825, 100826, 100827, 100828, 100830, 100831, 100832, 100833, 100834, 100835, 100837, 100840, 100842, 100843, 100848, 100849, 100850, 100851, 100852, 100853, 100854, 100855, 100856, 100857, 100858, 100859, 100860, 100861, 100862, 100863, 100865, 100866, 100867, 100868, 100869, 100870, 100871, 100872, 100873, 100874, 100875, 100876, 100877, 100878, 100879, 100880, 100881, 100882, 100883, 100884, 100885, 100887, 100888, 100889, 100890, 100891, 100892, 100893, 100894, 100895, 100896, 100897, 100898, 100899, 100900, 100901, 100902, 100903, 100904, 100905, 100906, 100907, 100908, 100909, 100910, 100911, 100912, 100913, 100914, 100915, 100917, 100918, 100919, 100920, 100921, 100922, 100924, 100925, 100926, 100927, 100928, 100929, 100930, 100931, 100932, 100933, 100934, 100935, 100936, 100937, 100938, 100939, 100940, 100941, 100942, 100943, 100944, 100945, 100946, 100947, 100948, 100949, 100950, 100951, 100952, 100953, 100954, 100955, 100956, 100957, 100958, 100959, 100960, 100961, 100962, 100963, 100965, 100966, 100967, 100968, 100970, 100971, 100972, 100973, 100974, 100975, 100976, 100977, 100978, 100979, 100980, 100981, 100982, 100984, 100985, 100986, 100987, 100989, 100990, 100991, 100992, 100993, 100994, 100995, 100996, 100997, 100998, 100999, 101000, 101001, 101002, 101004, 101005, 101006, 101007, 101008, 101009, 101010, 101011, 101012, 101013, 101014, 101015, 101016, 101017, 101019, 101020, 101021, 101022, 101023, 101024, 101025, 101026, 101027, 101028, 101029, 101031, 101032, 101033, 101035, 101036, 101037, 101038, 101041, 101043, 101044, 101045, 101046, 101047, 101048, 101049, 101050, 101051, 101052, 101053, 101054, 101055, 101056, 101057, 101058, 101059, 101060, 101061, 101063, 101064, 101065, 101066, 101067, 101068, 101069, 101071, 101072, 101074, 101075, 101076, 101077, 101078, 101079, 101080, 101081, 101082, 101083, 101084, 101085, 101086, 101087, 101088, 101089, 101090, 101091, 101092, 101094, 101095, 101096, 101097, 101098, 101099, 101100, 101101, 101102… Full codes in the FDA record | 16,525 units |
| Z-2018-2021 | INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173; a) V172, Serial Numbers: 100001, 100003, 100008, 100011, 100012, 100026, 100028, 100032, 100036, 100039, 100063, 100066, 100069, 100070, 100078, 100084, 100088, 100094, 100098, 100099, 100103, 100111, 100113, 100116, 100122, 100124, 100128, 100129, 100147, 100156, 100158, 100167, 100168, 100172, 100179, 100185, 100200, 100203, 100207, 100209, 100210, 100211, 100212, 100215, 100220, 100228, 100230, 100232, 100235, 100237, 100240, 100247, 100248, 100249, 100253, 100256, 100257, 100262, 100263, 100274, 100275, 100285, 100295, 100296, 100299, 100301, 100302, 100305, 100306, 100308, 100319, 100320, 100322, 100324, 100326, 100329, 100330, 100331, 100333, 100343, 100344, 100346, 100351, 100353, 100355, 100359, 100364, 100376, 100381, 100383, 100384, 100403, 100405, 100411, 100413, 100417, 100422, 100423, 100425, 100427, 100437, 100447, 100454, 100456, 100457, 100468, 100474, 100475, 100477, 100478, 100481, 100482, 100488, 100493, 100499, 100506, 100508, 100512, 100518, 100520, 100533, 100537, 100541, 100542, 100545, 100552, 100554, 100557, 100559, 100562, 100563, 100566, 100582, 100583, 100584, 100586, 100588, 100590, 100596, 100602, 100605, 100608, 100613, 100619, 100622, 100623, 100628, 100632, 100633, 100634, 100642, 100648, 100653, 100654, 100657, 100660, 100663, 100665, 100668, 100674, 100677, 100678, 100680, 100681, 100686, 100687, 102115, 102117, 102118, 102120 b) V173, Serial Numbers: 100005, 100008, 100009, 100012, 100015, 100016, 100063, 100064, 100066, 100069, 100077, 100078, 100080, 100084, 100086, 100088, 100090, 100092, 100094, 100096, 100099, 100100, 100101, 100102, 100105, 100112, 100113, 100114, 100118, 100120, 100121, 100122, 100124, 100125, 100129, 100134, 100135, 100136, 100138, 100140, 100144, 100147, 100148, 100150, 100152, 100154, 100155, 100159, 100162, 100165, 100166, 100167, 100171, 100172, 100177, 100178, 100179, 100180, 100181, 100183, 100184, 100185, 100187, 100190, 100193, 100195, 100196, 100197, 100198, 100199, 100200, 100203, 100205, 100208, 100210, 100213, 100214, 100216, 100219, 100220, 100224, 100226, 100227, 100229, 100235, 100238, 100239, 100240, 100242, 100245, 100246, 100248, 100250, 100252, 100254, 100255, 100256, 100262, 100263, 100266, 100271, 100272, 100273, 100280, 100282, 100285, 100287, 100288, 100290, 100296, 100297, 100300, 100301, 100304, 100305, 100306, 100317, 100319, 100320, 100321, 100324, 100327, 100328, 100335, 100337, 100338, 100339, 100340, 100343, 100347, 100349, 100353, 100355, 100357, 100358, 100359, 100361, 100362, 100364, 100368, 100376, 100379, 100384, 100388, 100390, 100393, 100396, 100398, 100483, 100484, 100486, 100487, 100490, 100492, 100496, 100501, 100502, 100507, 100511, 100513, 100516, 100517, 100522, 100523, 100526, 100527, 100532, 100534, 100535, 100541, 100544, 100545, 100546, 100548, 100549, 100551, 100553, 100556, 100560, 100562, 100563, 100564, 100571, 100572, 100573, 100574, 100575, 100576, 100581, 100582, 100583, 100584, 100585, 100586, 100587, 100592, 100596, 100598, 100604, 100605, 100608, 100611, 100618, 100624, 100625, 100626, 100629, 100630, 100632, 100634, 100635, 100638, 100640, 100644, 100645, 100646, 100647, 100650, 100651, 100652, 100654, 100655, 100656, 100660, 100661, 100668, 100669, 100670, 100674, 100677, 100680, 100683, 100685, 100687, 100688, 100691, 100697, 100698, 100699, 100702, 100706, 100707, 100710, 100711, 100714, 100717, 100719, 100722, 100723, 100725, 100726, 100728, 100730, 100731, 100732, 100737, 100741, 100746, 100751, 100753, 100754, 100760, 100762, 100763, 100765, 100770, 100771, 100772, 100775, 100777, 100781, 100783, 100787, 100791, 100792, 100795, 100797, 100801, 100803, 100807, 100808, 100809, 100817, 100821, 100822, 100823, 100826, 100829, 100830, 100831, 100833, 100836, 100837, 100838, 100840, 100841, 100842, 100843, 100844, 100848, 100850, 100853, 100856, 100859, 100860, 100862, 100863, 100864, 100867, 100868, 100869, 100871, 100872, 100874, 100877, 100879, 100880, 100882, 100883, 100884, 100887, 100889, 100891, 100893, 100898, 100900, 100903, 100904, 100905, 100908, 100910, 100911, 100912, 100916, 100919, 100920, 100924, 100925, 100931, 100932, 100933, 100934, 100935, 100938, 100939, 100941, 100944, 100947, 100949, 100954, 100957, 100958, 100959, 100961, 100963, 100964, 100965, 100968, 100969, 100971, 100972, 100977, 100978, 100981, 100984, 100985, 100987, 100988, 100989, 100990, 100991, 100992, 100993, 100998, 101001, 101003, 101004, 101005, 101008, 101009, 101012, 101013, 101014, 101016, 101020, 101022, 101025, 101031, 101033, 101034, 101046, 101047, 101048, 101049, 101052, 101053, 101055, 101060, 101062, 101064, 101066, 101067, 101069, 101071, 101072, 101074, 101076, 101077, 101078, 101080, 101081, 101083, 101086, 101090, 101091, 101092, 101095, 101097, 101098, 101104, 101105, 101110, 101113, 101114, 101115, 101117, 101118, 101119, 101120, 101125, 101128, 101133, 101134, 101135, 101136, 101137, 101140, 101141, 101142, 101144, 101146, 101147, 101152, 101156, 101157, 101162, 101163, 101166, 101174, 101175, 101177, 101179, 101180, 101181, 101182, 101187, 101189, 101190, 101198, 101199, 101200, 101202, 101208, 101212, 101213, 101214, 101216, 101218, 101219, 101221, 101222, 101223, 101224, 101225, 101226, 101228, 101229, 101240, 101247, 101248, 101249, 101251, 101252, 101253, 101254, 101255, 101257, 101258, 101260, 101262, 101264, 101265, 101267, 101269, 101270, 101271, 101274, 101277, 101281, 101284, 101289, 101290, 101291, 101293, 101294, 101300, 101304, 101306, 101307, 101308, 101309, 101311, 101313, 101314, 101315, 101318, 101319, 101320, 101321, 101331, 101332, 101333, 101337, 101339, 101340, 101341, 101344, 101345, 101346, 101348, 101349, 101350, 101351, 101352, 101354, 101356, 101358, 101363, 101372, 101373, 101377, 101382, 101383, 101384, 101386, 101390, 101391, 101392, 101395, 101397, 101398, 101400, 101404, 101405, 101407, 101408, 101409, 101410, 101412, 101415, 101416, 101417, 101418, 101419, 101420, 101422, 101425, 101426, 101431, 101432, 101434, 101436, 101437, 101439, 101443, 101444, 101445, 101447, 101448, 101451, 101452, 101454, 101456, 101459, 101465, 101468, 101471, 101472, 101475, 101478, 101479, 101482, 101484, 101485, 101487, 101490, 101494, 101495, 101496, 101498, 101499, 101500, 101502, 101506, 101507, 101508, 101509, 101511, 101516, 101517, 101518, 101519, 101520, 101521, 101524, 101525, 101530, 101531, 101532, 101533, 101535, 101536, 101538, 101540, 101541, 101543, 101545, 101546, 101547, 101548, 101549, 101557, 101558, 101559, 101560, 101565, 101566, 101567, 101569, 101574, 101575, 101577, 101579, 101580, 101582, 101583, 101584, 101585, 101586, 101587, 101588, 101591, 101592, 101593, 101596, 101597, 101598, 101600, 101601, 101603, 101604, 101607, 101608, 101609, 101610, 101615, 101616, 101617, 101618, 101620, 101622, 101623, 101625, 101629, 101633, 101635, 101636, 101639, 101640, 101641, 101643, 101645, 101646, 101648, 101649, 101650, 101653, 101655, 101658, 101659, 101660, 101662, 101665, 101667, 101668, 101672, 101675, 101676, 101678, 101680, 101681, 101682, 101683, 101684, 101687, 101691, 101695, 101698, 101700, 101701, 101702, 101704, 101705, 101707, 101708, 101709, 101710, 101712, 101713, 101714, 101721, 101722, 101725, 101726, 101727, 101729, 101731, 101732, 101733, 101734, 101736, 101742, 101743, 101745, 101746, 101750, 101753, 101755, 101757, 101759, 101760, 101761, 101762, 101763, 101766, 101768, 101771, 101773, 101779, 101782, 101783, 101785, 101787, 101789, 101790, 101793, 101796, 101797, 101798, 101799, 101802, 101805, 101807, 101810, 101813, 101814, 101816, 101817, 101820, 101823, 101825, 101826, 101828, 101829, 101833, 101838, 101839, 101840, 101841, 101842, 101843, 101845, 101848, 101850, 101854, 101855, 101857, 101858, 101859, 101860, 101861, 101862, 101863, 101869, 101870, 101872, 101874, 101878, 101879, 101880, 101882, 101883, 101885, 101887, 101888, 101889, 101892, 101895, 101897, 101898, 101899, 101900, 101901, 101908, 101909, 101911, 101912, 101914, 101915, 101917, 101921, 101923, 101924, 101926, 101929, 101930, 101935, 101936, 101937, 101940, 101941, 101942, 101944, 101945, 101946, 101948, 101949, 101954, 101955, 101957, 101961, 101963, 101967, 101968, 101970, 101973, 101979, 101980, 101982, 101983, 101984, 101989, 101991, 101992, 101994, 101995, 101996, 101997, 101999, 102001, 102002, 102003, 102004, 102006, 102009, 102015, 102017, 102018, 102020, 102022, 102025, 102027, 102029, 102030, 102031, 102034, 102035, 102036, 102040, 102041, 102043, 102049, 102050, 102054, 102055, 102056, 102057, 102058, 102060, 102061, 102062, 102065, 102066, 102069, 102070, 102072, 102075, 102076, 102079, 102080, 102081, 102083, 102084, 102085, 102086, 102088, 102089, 102090, 102094, 102096, 102097, 102098, 102099, 102100, 102101, 102103, 102104, 102106, 102108, 102110, 102120, 102122, 102123, 102124, 102125, 102126, 102128, 102130, 102132, 102133, 102134, 102135, 102138, 102141, 102146, 102148, 102153, 102154, 102158, 102159, 102160, 102163, 102164, 102166, 102169, 102171, 102172, 102173, 102174, 102178, 102179, 102182, 102186, 102187, 102188, 102190, 102193, 102195, 102199, 102201, 102202, 102204, 102205, 102206, 102209, 102210, 102213, 102215, 102217, 102220, 102222, 102224, 102227, 102233, 102237, 102238, 102240, 102241, 102248, 102249, 102250, 102251, 102255, 102256, 102257, 102258, 102261, 102262, 102268, 102269, 102270, 102272, 102273, 102276, 102277, 102279, 102280, 102282, 102283, 102284, 102285, 102287, 102288, 102290, 102294, 102296, 102298, 102299, 102302, 102303, 102304, 102307, 102311, 102312, 102317, 102318, 102319, 102321, 102326, 102331, 102333, 102335, 102336, 102338, 102339, 102341, 102346, 102359, 102360, 102362, 102368, 102369, 102372, 102374, 102375, 102378, 102379, 102381, 102383, 102385, 102391, 102394, 102395, 102396, 102398, 102400, 102401, 102402, 102404, 102407, 102409, 102410, 102415, 102417, 102420, 102421, 102424, 102430, 102435, 102438, 102439, 102443, 102445, 102446, 102453, 102456, 102459, 102461, 102463, 102465, 102467, 102469, 102470, 102472, 102474, 102476, 102481, 102484, 102486, 102487, 102489, 102493, 102495, 102498, 102501, 102502, 102503, 102506, 102508, 102509, 102510, 102514, 102515, 102517, 102518, 102519, 102521, 102522, 102523, 102525, 102526, 102533, 102534, 102536, 102541, 102546, 102547, 102548, 102549, 102550, 102554, 102556, 102560, 102563, 102565, 102567, 102569, 102573, 102578, 102582, 102583, 102584, 102585, 102586, 102590, 102595, 102597, 102598, 102602, 102604, 102607, 102609, 102610, 102612, 102613, 102615, 102616, 102617, 102618, 102619, 102620, 102621, 102622, 102625, 102626, 102627, 102628, 102631, 102632, 102633, 102637, 102638, 102641, 102643, 102646, 102649, 102650, 102654, 102657, 102658, 102659, 102660, 102662, 102665, 102668, 102671, 102672, 102674, 102679, 102682, 102683, 102684, 102687, 102691, 102692, 102694, 102696, 102699, 102701, 102704, 102705, 102709, 102710, 102715, 102716, 102718, 102720, 102722, 102724, 102729, 102730, 102732, 102733, 102734, 102735, 102736, 102738, 102741, 102742, 102744, 102745, 102746, 102749, 102751, 102753, 102756, 102757, 102761, 102766, 102768, 102769, 102771, 102773, 102774, 102775, 102776, 102777, 102779, 102780, 102783, 102785, 102788, 102789, 102790, 102792, 102793, 102794, 102795, 102798, 102799, 102801, 102802, 102803, 102804, 102806, 102810, 102811, 102813, 102814, 102816, 102819, 102820, 102821, 102822, 102826, 102827, 102829, 102830, 102831, 102832, 102837, 102838, 102839, 102842, 102845, 102846, 102847, 102852, 102853, 102855, 102858, 102860, 102861, 102862, 102863, 102864, 102865, 102867, 102870, 102871, 102872, 102874, 102876, 102878, 102879, 102884, 102886, 102887, 102888, 102889, 102890, 102891, 102893, 102896, 102897, 102898, 102899, 102900, 102902, 102904, 102906, 102911, 102912, 102918, 102920, 102921, 102922, 102928, 102930, 102936, 102937, 102938, 102942, 102943, 102944, 102947, 102948, 102949, 102952, 102954, 102957, 102958… Full codes in the FDA record | 13332 units |
| Z-2019-2021 | INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273; a) V272, Serial Numbers: 100002, 100014, 100017, 100021, 100028, 100037, 100048, 100052, 100053, 100054, 100065, 100067, 100068, 100075, 100077, 100080, 100092, 100093, 100096, 100097, 100098, 100099, 100101, 100104, 100106, 100107, 100108, 100114, 100116, 100118, 100119, 100120, 100124, 100127, 100136, 100152, 100153, 100155, 100159, 100161, 100162, 100165, 100168, 100170, 100171, 100173, 100175, 100176, 100179, 100194, 100195, 100199, 100201, 100202, 100203, 100205, 100206, 100211, 100212, 100216, 100218, 100219, 100221, 100224, 100226, 100227, 100228, 100230, 100232, 100233, 100237, 100238, 100240, 100241, 100242, 100245, 100247, 100249, 100250, 100253, 100256, 100257, 100258, 100261, 100266, 100270, 100272, 100276, 100277, 100280, 100281, 100287, 100289, 100290, 604977, 604982, 604984, 604986, 604987, 604988, 604991, 604992, 604998, 604999, 605002, 605003, 605004, 605005, 605006, 605007, 605009, 605010, 605011, 605013, 605014, 605015, 605017, 605020, 605021, 605022, 605023, 605025, 605026, 605027, 605028, 605029, 605035, 605036, 605037, 605039, 605041, 605047, 605049, 605051, 605052, 605055, 605057, 605058, 605061, 605062, 605063, 605064, 605065, 605070, 605073, 605075, 605076, 605079, 605080, 605082, 605085, 605087, 605088, 605090, 605096, 605098, 605099, 605100, 605103, 605108, 605112, 605115, 605117, 605118, 605120, 605124, 605127, 605128, 605129, 605133, 605135, 605136, 605137, 605140, 605141, 605147, 605149, 605150, 605151, 605152, 605153, 605154, 605155, 605158, 605159, 605161, 605162, 605163, 605164, 605166, 605168, 605170, 605172, 605173, 605174, 605175, b) V273, Serial Numbers: 100001, 100002, 100006, 100007, 100013, 100014, 100015, 100017, 100019, 100030, 100032, 100033, 100034, 100035, 100036, 100037, 100038, 100042, 100044, 100045, 100046, 100047, 100048, 100049, 100054, 100056, 100057, 100058, 100060, 100062, 100066, 100067, 100069, 100071, 100072, 100076, 100083, 100084, 100086, 100087, 100088, 100089, 100090, 100091, 100093, 100096, 100097, 100100, 100101, 100103, 100104, 100107, 100116, 100117, 100118, 100119, 100120, 100121, 100123, 100126, 100128, 100131, 100134, 100135, 100138, 100139, 100140, 100141, 100142, 100143, 100146, 100148, 100152, 100154, 100155, 100156, 100157, 100159, 100166, 100168, 100174, 100175, 100180, 100182, 100184, 100185, 100187, 100192, 100197, 100199, 100201, 100202, 100206, 100209, 100211, 100212, 100213, 100219, 100227, 100229, 100230, 100232, 100234, 100235, 100237, 100241, 100242, 100244, 100245, 100249, 100250, 100251, 100253, 100254, 100255, 100259, 100263, 100265, 100266, 100270, 100275, 100277, 100284, 100285, 100286, 100288, 100289, 100290, 100294, 100296, 100298, 100299, 100300, 100301, 100302, 100303, 100304, 100306, 100307, 100309, 100311, 100317, 100319, 100320, 100321, 100322, 100323, 100324, 100325, 100326, 100327, 100328, 100333, 100334, 100335, 100336, 100339, 100340, 100341, 100344, 100345, 100347, 100348, 100349, 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117851, 117852, 117854, 117855, 117856, 117857, 117860, 117863, 117865, 117866, 117867, 117868, 117869, 117871, 117872, 117873, 117876, 117877, 117881, 117882, 117883, 117884, 117885, 117886, 117887, 117888, 117889, 117890, 117891, 117892, 117894, 117895, 117896, 117897, 117900, 117901, 117902, 117903, 117904, 117905, 117906, 117907, 117908, 117910, 117911, 117912, 117913, 117916, 117918, 117919, 117920, 117921, 117922, 117923, 117924, 117925, 117926, 117927, 117929, 117930, 117932, 117935, 117936, 117937, 117938, 117944, 117947, 117948, 117951, 117952, 117953, 117954, 117956, 117959, 117960, 117961, 117962, 117964, 117965, 117966, 117967, 117969, 117971, 117972, 117974, 117975, 117976, 117977, 117978, 117979, 117980, 117981, 117983, 117984, 117986, 117989, 117991, 117992, 117993, 117994, 117995, 117996, 117997, 117998, 118001, 118002, 118005, 118006, 118007, 118008, 118009, 118010, 118013, 118015, 118016, 118019, 118021, 118022, 118023, 118024, 118026, 118027, 118028, 118029, 118031, 118032, 118033, 118035, 118036, 118037, 118038, 118040, 118041, 118046, 118047, 118049, 118051, 118052, 118054, 118055, 118056, 118057, 118058, 118059, 118062, 118063, 118066, 118068, 118069, 118070, 118072, 118074, 118075, 118076, 118077, 118078, 118081, 118084, 118085, 118087, 118088, 118091, 118094, 118095, 118096, 118098, 118101, 118104, 118105, 118106, 118108, 118109, 118110, 118111, 118113, 118114, 118115, 118116, 118118, 118119, 118120, 118121, 118122, 118123, 118124, 118125, 118127, 118129, 118130, 118131, 118133, 118134, 118135, 118136, 118138, 118141, 118143, 118145, 118147, 118148, 118149, 118150, 118152, 118153, 118154, 118155, 118156, 118158, 118159, 118163, 118164, 118167, 118168, 118169, 118170, 118173, 118174, 118175, 118176, 118177, 118178, 118179, 118181, 118182, 118185, 118186, 118187, 118188, 118189, 118190, 118191, 118192, 118193, 118194, 118195, 118197, 118198, 118199, 118200, 118201, 118203, 118206, 118208, 118211, 118212, 118213, 118217, 118218, 118219, 118223, 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118478, 118479, 118481, 118482, 118483, 118484, 118486, 118487, 118489, 118490, 118491, 118492, 118493, 118495, 118496, 118497, 118498, 118500, 118501, 118503, 118505, 118506, 118507, 118509, 118510, 118511, 118512, 118513, 118518, 118520, 118524, 118525, 118526, 118527, 118529, 118530, 118532, 118534, 118535, 118536, 118537, 118538, 118539, 118541, 118543, 118545, 118546, 118550, 118551, 118552, 118553, 118554, 118555, 118559, 118560, 118563, 118564, 118565, 118567, 118568, 118569, 118570, 118572, 118575, 118577, 118578, 118587, 118588, 118590, 118592, 118595, 118597, 118599, 118600, 118601, 118602, 118603, 118604, 118605, 118606, 118607, 118608, 118609, 118610, 118611, 118614, 118618, 118619, 118620, 118621, 118623, 118627, 118630, 118631, 118633, 118635, 118636, 118637, 118639, 118641, 118642, 118643, 118644, 118647, 118649, 118651, 118652, 118654, 118655, 118657, 118658, 118659, 118661, 118662, 118663, 118666, 118668, 118669, 118670, 118672, 118673, 118674, 118675, 118677, 118678… Full codes in the FDA record | 1707 units |
| Z-2020-2021 | INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021); a) V284, Serial Numbers: 100002, 100000, 100003, 100005, 100009, 100010, 100011, 100012, 100014, 100015, 100016, 100017, 100018, 100019, 100022, 100023, 100027, 100029, 234350, 234352 b) V285, Serial Numbers: 246521, 100000, 100002, 100007, 100018, 100026, 100036, 100059, 100065, 100087, 100097, 100101, 100111, 100117, 100126, 100127, 100136, 100139, 100141, 100154, 100156, 100158, 100159, 100161, 100162, 100163, 246441, 246442, 246446, 246447, 246449, 246451, 246453, 246458, 246459, 246463, 246469, 246470, 246471, 246472, 246473, 246474, 246475, 246477, 246481, 246483, 246484, 246485, 246486, 246495, 246496, 246497, 246499, 246500, 246501, 246503, 246504, 246505, 246506, 246508, 246509, 246512, 246519, 246520, 246521, 246527, 246529, 246532, 246534, 246542, 246546, 246549, 246554, 246577, 246586, 246590, 246591, 246592, 246593, 246596, 246598, 246610, 246611, 246613, 246619, 246623, 246627, 246628, 246630, 246634, 246636, 246637, 246645, 246646, 246647, 246650, 246654, 246656, 246658, 246664, 246665, 246667, 246672, 246673, 246677, 246679, 246681, 246683, 246686, 246688, 246690, 246693, 246694, 246697, 246704, 246709, 246710, 246713, 246714, 246721, 246730, 246748, 246752, 246756, 246759, 246762, 246764, 246765, 246766, 246769, 100003, 100004, 100005, 100008, 100009, 100010, 100012, 100013, 100015, 100016, 100017, 100019, 100020, 100021, 100023, 100025, 100027, 100028, 100029, 100030, 100031, 100032, 100033, 100035, 100037, 100038, 100039, 100040, 100042, 100043, 100046, 100047, 100048, 100049, 100050, 100051, 100052, 100053, 100054, 100055, 100056, 100057, 100058, 100060, 100061, 100062, 100066, 100067, 100068, 100069, 100071, 100072, 100074, 100075, 100076, 100077, 100079, 100080, 100081, 100082, 100083, 100084, 100085, 100086, 100091, 100093, 100095, 100098, 100100, 100102, 100103, 100104, 100105, 100106, 100107, 100108, 100109, 100110, 100112, 100114, 100115, 100116, 100118, 100119, 100120, 100121, 100122, 100123, 100124, 100125, 100129, 100130, 100131, 100132, 100133, 100134, 100135, 100137, 100138, 100140, 100142, 100143, 100144, 100145, 100146, 100147, 100148, 100149, 100150, 100151, 100152, 100153, 100155, 100157, 100160, 100164, 246436, 246437, 246438, 246439, 246440, 246443, 246444, 246445, 246448, 246450, 246452, 246454, 246455, 246456, 246460, 246461, 246462, 246464, 246465, 246466, 246467, 246476, 246478, 246480, 246482, 246487, 246488, 246489, 246490, 246491, 246492, 246493, 246494, 246498, 246502, 246507, 246510, 246511, 246514, 246515, 246516, 246518, 246522, 246524, 246525, 246526, 246528, 246530, 246535, 246541, 246543, 246544, 246545, 246548, 246550, 246551, 246552, 246555, 246556, 246558, 246559, 246560, 246561, 246564, 246566, 246567, 246568, 246569, 246570, 246571, 246572, 246573, 246574, 246575, 246576, 246578, 246579, 246580, 246581, 246582, 246583, 246584, 246585, 246587, 246588, 246589, 246594, 246595, 246597, 246602, 246603, 246604, 246606, 246607, 246608, 246609, 246614, 246615, 246616, 246617, 246618, 246620, 246621, 246622, 246624, 246625, 246626, 246629, 246631, 246633, 246635, 246640, 246641, 246642, 246643, 246644, 246649, 246651, 246652, 246653, 246655, 246657, 246659, 246660, 246661, 246662, 246663, 246668, 246670, 246675, 246676, 246678, 246680, 246682, 246684, 246685, 246687, 246691, 246692, 246695, 246696, 246698, 246699, 246700, 246701, 246702, 246703, 246705, 246706, 246708, 246711, 246712, 246715, 246717, 246718, 246719, 246720, 246723, 246724, 246725, 246726, 246728, 246729, 246731, 246732, 246733, 246734, 246736, 246738, 246739, 246740, 246741, 246742, 246743, 246744, 246745, 246746, 246749, 246750, 246751, 246755, 246757, 246758, 246767 c) W274, Serial Numbers: 111154, 111189, 111247, 111112, 111113, 111114, 111115, 111118, 111119, 111120, 111121, 111122, 111124, 111125, 111127, 111128, 111131, 111133, 111134, 111136, 111138, 111139, 111140, 111142, 111143, 111144, 111145, 111147, 111148, 111149, 111150, 111151, 111152, 111155, 111158, 111159, 111163, 111164, 111165, 111166, 111167, 111168, 111169, 111171, 111173, 111174, 111175, 111176, 111177, 111180, 111181, 111184, 111185, 111186, 111187, 111188, 111191, 111192, 111193, 111195, 111196, 111197, 111198, 111199, 111203, 111204, 111205, 111206, 111208, 111209, 111211, 111213, 111214, 111215, 111216, 111220, 111221, 111222, 111225, 111226, 111227, 111230, 111231, 111232, 111233, 111234, 111236, 111237, 111241, 111242, 111244, 111249, 111250, 111251, 111256, 111257, 111261, 111262, 111264, 111267, 111268, 111270, 111271, 111272, 111275, 111276, 111278, 111279, 111281, 111282, 111284, 111285, 111288, 111289, 111293, 111294, 111299, 111300, 111301, 111302, 111304, 111305, 111307, 111312, 111314, 111316, 111317, 111323, 111327, 111328, 111332, 111334, 111336, 111337, 111338, 111341, 111343, 111345, 111346, 111347, 111348, 111349, 111350, 111351, 111356, 111357, 111358, 111359, 111360, 111362, 111363, 111365, 111366, 111367, 111368, 111369, 111370, 111372, 111373, 111374, 111378, 111380, 111381, 111382, 111385, 111387, 111388, 111389, 111390, 111391, 300711, 300713, 300714, 300716, 300717, 300718, 300719, 300731 d) W275, Serial Numbers: 111149, 111152, 111164, 111166, 111178, 111189, 111190, 111207, 111217, 111218, 111230, 111256, 111287, 111310, 111321, 111363, 111373, 111379, 111394, 111397, 111405, 111407, 111417, 111423, 111441, 111466, 111472, 111484, 111486, 111489, 111516, 111519, 111524, 111536, 111545, 111559, 111566, 111593, 111609, 111613, 111692, 111703, 111709, 111765, 111773, 111820, 111826, 111842, 111883, 111959, 111974, 111991, 112097, 112159, 112165, 112194, 112226, 112284, 112367, 112459, 112469, 112473, 112497, 112500, 112574, 112578, 112642, 112644, 112685, 112691, 112710, 112711, 112724, 112958, 112982, 112994, 112999, 113042, 113059, 113061, 113126, 113137, 113144, 113175, 113192, 113295, 113297, 113302, 113322, 113377, 113416, 113444, 113550, 300827, 300843, 300955, 301017, 301059, 301132, 301155, 301185, 301256, 301259, 301261, 301263, 301264, 301265, 301267, 301270, 301271, 301272, 301273, 301275, 301277, 301281, 301282, 301284, 301289, 301293, 301296, 301300, 301302, 301305, 301306, 301363, 301364, 301371, 301377, 301398, 301478, 301480, 301491, 301494, 111119, 111120, 111121, 111122, 111123, 111124, 111125, 111127, 111128, 111129, 111130, 111131, 111132, 111133, 111135, 111136, 111137, 111138, 111139, 111140, 111141, 111142, 111143, 111144, 111145, 111146, 111147, 111148, 111150, 111151, 111153, 111154, 111155, 111156, 111157, 111158, 111159, 111160, 111161, 111162, 111163, 111165, 111167, 111168, 111169, 111170, 111171, 111173, 111174, 111175, 111176, 111177, 111179, 111180, 111181, 111182, 111183, 111184, 111186, 111187, 111188, 111191, 111193, 111194, 111195, 111196, 111197, 111198, 111199, 111200, 111201, 111202, 111203, 111205, 111206, 111208, 111209, 111210, 111211, 111212, 111214, 111215, 111216, 111219, 111220, 111221, 111222, 111223, 111224, 111225, 111226, 111227, 111228, 111229, 111231, 111233, 111234, 111235, 111236, 111237, 111238, 111239, 111240, 111241, 111242, 111243, 111244, 111245, 111246, 111247, 111248, 111249, 111250, 111251, 111252, 111253, 111255, 111257, 111258, 111260, 111263, 111265, 111267, 111268, 111269, 111270, 111271, 111272, 111273, 111274, 111275, 111276, 111277, 111279, 111281, 111283, 111284, 111285, 111286, 111289, 111291, 111293, 111294, 111296, 111297, 111298, 111300, 111301, 111303, 111304, 111307, 111308, 111309, 111311, 111312, 111313, 111315, 111316, 111317, 111318, 111319, 111320, 111322, 111323, 111325, 111326, 111327, 111328, 111329, 111331, 111332, 111333, 111334, 111335, 111336, 111337, 111338, 111339, 111342, 111343, 111344, 111345, 111346, 111348, 111349, 111350, 111351, 111352, 111353, 111354, 111355, 111356, 111357, 111359, 111360, 111361, 111362, 111364, 111366, 111367, 111368, 111369, 111370, 111371, 111372, 111376, 111378, 111380, 111381, 111382, 111383, 111384, 111386, 111387, 111388, 111389, 111390, 111391, 111392, 111396, 111398, 111399, 111400, 111401, 111403, 111404, 111406, 111408, 111409, 111410, 111411, 111412, 111414, 111415, 111416, 111419, 111420, 111421, 111422, 111424, 111425, 111427, 111428, 111429, 111430, 111431, 111432, 111433, 111434, 111435, 111436, 111437, 111439, 111440, 111442, 111443, 111444, 111445, 111446, 111447, 111448, 111449, 111450, 111451, 111452, 111453, 111454, 111455, 111456, 111457, 111459, 111460, 111461, 111462, 111463, 111464, 111465, 111467, 111468, 111469, 111471, 111474, 111475, 111476, 111477, 111478, 111479, 111480, 111481, 111483, 111485, 111488, 111490, 111491, 111492, 111493, 111495, 111496, 111498, 111499, 111500, 111501, 111503, 111504, 111505, 111506, 111507, 111508, 111509, 111510, 111511, 111512, 111513, 111514, 111515, 111517, 111518, 111520, 111521, 111522, 111523, 111525, 111528, 111529, 111530, 111532, 111533, 111534, 111535, 111539, 111541, 111542, 111543, 111544, 111546, 111547, 111548, 111549, 111550, 111551, 111552, 111553, 111554, 111555, 111556, 111557, 111558, 111560, 111561, 111562, 111564, 111565, 111567, 111568, 111569, 111570, 111571, 111572, 111574, 111576, 111578, 111579, 111580, 111581, 111582, 111583, 111585, 111586, 111587, 111588, 111590, 111591, 111594, 111595, 111596, 111597, 111598, 111599, 111600, 111601, 111602, 111604, 111605, 111606, 111607, 111608, 111610, 111612, 111614, 111618, 111619, 111620, 111621, 111622, 111623, 111624, 111626, 111627, 111628, 111629, 111630, 111631, 111632, 111633, 111635, 111636, 111637, 111638, 111639, 111640, 111641, 111643, 111644, 111645, 111647, 111648, 111649, 111652, 111653, 111654, 111655, 111656, 111658, 111659, 111660, 111661, 111662, 111663, 111664, 111665, 111666, 111668, 111669, 111670, 111671, 111672, 111673, 111675, 111676, 111677, 111678, 111679, 111680, 111682, 111684, 111685, 111686, 111687, 111688, 111689, 111690, 111693, 111695, 111696, 111697, 111699, 111700, 111701, 111704, 111705, 111706, 111707, 111710, 111711, 111712, 111713, 111714, 111715, 111716, 111717, 111718, 111719, 111720, 111721, 111722, 111723, 111724, 111725, 111726, 111727, 111729, 111730, 111731, 111732, 111733, 111734, 111735, 111736, 111737, 111738, 111739, 111740, 111741, 111742, 111743, 111744, 111745, 111746, 111747, 111748, 111749, 111750, 111751, 111752, 111753, 111754, 111755, 111756, 111757, 111758, 111759, 111760, 111761, 111762, 111763, 111764, 111766, 111767, 111768, 111770, 111771, 111772, 111774, 111775, 111776, 111777, 111778, 111779, 111780, 111781, 111782, 111783, 111784, 111785, 111787, 111788, 111789, 111790, 111792, 111793, 111794, 111795, 111796, 111798, 111799, 111800, 111801, 111802, 111803, 111804, 111805, 111806, 111808, 111809, 111810, 111811, 111812, 111813, 111814, 111815, 111816, 111817, 111818, 111819, 111821, 111822, 111823, 111824, 111825, 111827, 111828, 111829, 111830, 111831, 111833, 111834, 111835, 111836, 111837, 111838, 111839, 111840, 111841, 111843, 111845, 111846, 111847, 111849, 111850, 111851, 111852, 111853, 111855, 111856, 111857, 111859, 111860, 111861, 111862, 111863, 111864, 111866, 111867, 111868, 111869, 111870, 111871, 111872, 111873, 111874, 111875, 111876, 111877, 111878, 111879, 111880, 111881, 111882, 111884, 111885, 111886, 111888, 111889, 111890, 111891, 111893, 111894, 111895, 111896, 111897, 111898, 111899, 111900, 111902, 111903, 111904, 111905, 111906, 111907, 111908, 111909, 111910, 111911, 111912, 111913, 111914, 111915, 111916, 111917, 111918, 111920, 111921, 111922, 111923, 111924, 111925, 111926, 111928, 111930, 111931, 111932, 111933, 111934, 111935, 111936, 111937, 111938, 111939, 111940, 111941, 111942, 111943, 111944, 111945, 111946, 111948, 111949, 111951, 111952, 111953, 111954, 111955, 111956, 111957, 111958, 111960, 111961, 111963, 111964, 111965, 111966, 111967, 111968, 111969, 111970, 111971, 111972, 111973, 111975, 111976, 111977, 111978, 111979, 111980, 111981, 111982, 111983, 111984, 111985, 111986, 111987, 111989, 111990, 111992, 111993… Full codes in the FDA record | 3634 units |
What to do — step by step
Check device model and battery
Identify your device model (V284, V285, W274, or W275) and confirm it has an Extended Life battery. Check the serial numbers against the list provided in the recall notice.
Contact Boston Scientific
Reach out to Boston Scientific directly to confirm your device is affected and schedule a replacement.
How this recall unfolded
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-2020-2021 (June 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2020-2021 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.