Use caution Medical device recall · FDA · Published January 30, 2025

Medtronic Pipeline Vantage Embolization Device with Shield Technology recall: Risk

Medtronic Pipeline Vantage Embolization Device with Shield Technology (REFs PED3-021-350-16, etc.) may cause incomplete wall apposition and braid deformation (fish-mouthing) in procedures ≥4mm diameter, potentially leading to thrombosis. Higher risk in women ≤45 years. Check product codes for recall.

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

🇺🇸 FDA recall #Z-1246-2025Medical device Micro Therapeutics ›

Use caution until it’s fixed

Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age

Take action

Contact the company

Recalling firmMicro Therapeutics, Inc.9775 Toledo Way · Irvine, CA 92618-1811

✎ GovInfoNow plain-language explainer

Micro Therapeutics recalls certain Medtronic Pipeline Vantage Embolization Devices with Shield Technology that may cause incomplete wall apposition and braid deformation (fish-mouthing) during procedures, especially in devices ≥4mm diameter. This can lead to thrombosis or serious complications, with higher risk for women aged 45 or younger. Read more at govinfonow.com/recall/53011-medtronic-pipeline-vantage-embolization-device-with-shield-technology-recall-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53011-medtronic-pipeline-vantage-embolization-device-with-shield-technology-recall-risk · Updated September 23, 2026 · FDA enforcement record: FDA #Z-1246-2025

Cite this page

“Medtronic Pipeline Vantage Embolization Device with Shield Technology recall: Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53011-medtronic-pipeline-vantage-embolization-device-with-shield-technology-recall-risk. Based on FDA recall #Z-1246-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1246-2025%22&limit=1).

The FDA announced on Jan. 30, 2025, that Micro Therapeutics, Inc. is recalling Medtronic Pipeline Vantage Embolization Devices with Shield Technology due to potential braid deformation and thrombosis risks. The recall affects approximately 7,820 units distributed worldwide.

How to tell if you have it

Brand: Micro Therapeutics
Product: Medtronic Pipeline Vantage Embolization Device with Shield Technology
REFs: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18
Lot codes: B317460 through B807417 (as listed in record)
Quantity: 7,820 units

The hazard

Use of embolization devices with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation, such as fish-mouthing or braid collapse. This issue is typically noted at 6-12 month imaging follow-up and can potentially lead to thrombosis and/or serious adverse events. The hazard presents a higher risk in females less-than-or-equal-to 45 years of age.

Context

GovInfoNow's records show Micro Therapeutics, Inc. has 6 other recalls on record since July 13, 2021. Other recent recalls of similar products include the Boston Scientific FARADRIVE Steerable Sheath Recall for Risk of Air Embolism (June 11, 2026) and the Boston Scientific FARADRIVE Steerable Sheath Clear IDE Recall for Risk of Air Embolism from Valve Damage (June 11, 2026).

How to tell if you have this one

Check the product reference codes (REFs) listed in the recall notice: PED3-021-350-16, PED3-021-250-14, and other specific codes. The device is used in medical procedures for embolization.

Brand
Micro Therapeutics
Category
Medical device

FDA recall event · 2 products

All 2 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: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And OUS (foreign) countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Martinique, Mexico, Republic Of Moldova, Montenegro, Morocco, Netherlands, New Zealand, North Macedonia, Northern Ireland, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam

Recall number	Product, codes & lots	Quantity
Z-1245-2025	Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50; All unused devices. Product lots including and between B317266 and B817292. REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548; PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880; PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808; PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630; PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938; PED3-027-400-12/00847536030862, 00847536035362, 00847536036680/B321585, B336094, B349668,B371137, B409814, B414591, B437740, B482271, B594119, B597085, B598465, B612514, B616043, B616052, B647374, B649853, B655648, B658620, B658685, B666385, B666418, B671805, B720634, B720635, B744619, B744621, B756639, B765446, B765448, B780611, B786108; PED3-027-400-14/00847536030879, 00847536035379, 00847536036697/B318079, B335275, B339540, B350391, B364366, B372416, B375523, B410879, B415080, B422400, B438538, B448437, B459694, B460349, B464650, B469525, B474550, B556978, B601007, B608852, B616050, B622657, B625452, B625453, B629552, B683800, B689019, B691414, B698756, B714840, B715051, B721683, B745065, B753732, B763635, B763642, B802419; PED3-027-400-16/00847536030886, 00847536035386, 00847536036703/B326193, B330879, B330881, B357080, B401867, B402034, B403012, B417737, B419736, B420127, B422990, B423257, B426548, B438677, B439156, B439301, B445198, B449040, B449149, B449591, B453559, B454843, B459846, B460523, B465307, B469682, B474417, B560503, B575892, B578340, B597083, B603196, B608221, B611268, B615571, B623135, B623136, B625944, B625945, B672865, B678987, B694225, B694934, B699098, B715043, B721778, B721782, B730828, B730829, B738422, B738423, B739914, B744842, B744860, B766155, B766701, B769315, B776922, B776933, B777378, B791207; PED3-027-400-18/00847536036710/B795091; PED3-027-400-20/00847536030909, 00847536035409, 00847536036727/B318459, B329314, B329316, B338468, B368540, B374265, B380481, B381434, B383600, B384092, B384233, B388982, B391816, B420182, B420318, B423735, B439714, B441852, B449699, B450256, B460915, B461092, B461510, B465420, B470193, B475106, B478030, B485264, B487677, B557537, B565556, B571634, B575122, B576711, B577356, B578341, B631830, B632949, B635238, B636674, B649884, B654937, B657799, B658273, B658540, B659188, B659211, B666546, B671140, B679007, B680109, B692381, B692536, B692916, B693469, B705994, B722574, B722592, B730946, B739972, B741664, B741666, B746709, B752946, B753532, B756807, B756808, B763701, B778174, B778192, B778193, B778534, B778535, B781327, B781347, B791327, B811796; PED3-027-400-25/00847536030916, 00847536035416, 00847536036734/B322422, B394134, B400793, B411501, B415161, B424676, B432804, B442338, B470284, B474964, B481516, B483308, B568647, B576712, B577358, B634985, B636192, B648012, B649383, B661189, B675951, B689989, B704525, B706229, B706230, B709931, B712123, B726423, B741049, B741051, B747537, B747541, B754030, B765519, B776777, B777166, B780003, B780520, B786557; PED3-027-400-30/00847536030923, 00847536035423, 00847536036741/B394830, B401265, B413855, B415343, B415743, B444760, B470728, B475566, B484529, B594121, B603201, B608917, B616555, B622661, B623126, B637143, B675952, B681380, B681596, B711437, B711438, B723555, B731515, B731516, B741809, B764098, B778206, B778207, B798796; PED3-027-450-12/00847536030961, 00847536035461, 00847536036789/B322748, B456666, B471328, B486866, B575963, B601277, B637185, B666423, B703226, B706228, B708791, B711095, B750794, B751129, B758665, B758666, B758667, B794235; PED3-027-450-14/00847536030978, 00847536035478, 00847536036796/B320465, B336565, B340244, B351032, B374880, B404541, B425289, B432042, B462206, B470900, B477408, B481700, B483148, B601181, B604476, B617556, B637191, B669563, B669568, B675953, B692841, B694794, B696125, B697448, B704465, B709288, B711828, B719080, B719084, B741791, B745142, B745143, B751967, B753463, B772618, B814124; PED3-027-450-16/00847536030985, 00847536035485, 00847536036802/B318562, B331383, B331528, B340320, B351038, B374958, B384705, B385273, B395007, B405061, B407737, B424599, B450972, B465971, B471455, B483899, B485855, B535234, B552285, B568744, B571592, B585330, B596585, B622035, B625593, B626044, B628700, B629503, B643420, B659204, B659718, B660616, B661809, B666550, B666589, B668758, B669369, B675954, B682011, B698182, B723071, B723072, B723787, B723791, B735828, B735829, B735830, B746751, B746752, B753483, B757640, B757645, B762226, B762228, B764394, B787789, B789383, B803301; PED3-027-450-18/00847536036819/B797308; PED3-027-450-20/00847536031005, 00847536035508, 00847536036826/B325710, B328706, B328709, B355336, B357077, B357672, B377120, B381729, B389289, B390355, B397986, B419639, B421094, B423116, B425691, B440190, B440356, B440859, B442521, B449796, B450384, B451092, B452205, B461652, B462339, B464094, B480010, B481041, B487030, B549631, B550980, B557508, B569276, B573461, B574475, B584490, B585331, B594727, B632801, B635651, B650035, B651312, B651584, B652220, B669427, B673379, B674005, B681938, B696501, B696960, B700714, B700961, B703735, B705508, B728234, B729519, B732220, B752592, B758912, B758914, B760821, B774880, B776153, B794615, B794620, B798765, B810476, B811668; PED3-027-450-25/00847536031012, 00847536035515, 00847536036833/B319170, B352790, B370633, B395978, B403146, B408241, B419571, B425960, B443719, B453438, B453676, B463202, B467023, B471895, B472002, B488714, B558531, B590206, B596591, B597131, B600999, B604474, B604478, B611115, B613070, B616042, B645444, B645874, B646698, B652027, B654357, B681223, B681901, B693373, B696977, B697584, B699639, B699762, B730899, B751210, B751305, B752452, B759553, B759554, B775532, B800797; PED3-027-450-30/00847536031029, 00847536035522, 00847536036840/B396144, B404416, B411353, B434096, B436536, B535757, B561797, B574352, B616037, B644866, B645276, B651451, B652656, B654460, B658656, B659930, B675955, B688941, B713232, B714797, B714798, B717097, B730298, B731601, B731603, B784372, B785363, B810615, B815818; PED3-027-450-40/00847536031043, 00847536035546, 00847536036864/B353358, B377744, B411399, B448343, B549634, B559739, B615408, B623125, B637017, B675956, B683288, B684783, B699735, B699776, B704439, B710043, B710051, B733018, B761384, B761385, B761386, B764292, B778738, B778836, B786518; PED3-027-500-14/00847536031067, 00847536035577, 00847536036895/B353371, B411952, B425824, B432210, B447358, B455035, B455951, B601160, B603379, B606137, B624428, B637037, B651443, B674478, B675957, B685652, B701387, B706116, B706164, B710564, B710571, B711705, B729531, B764751, B765289, B785958, B790520; PED3-027-500-16/00847536031074, 00847536035584, 00847536036901/B320910, B353996, B375682, B425116, B426932, B432683, B441009, B479353, B536475, B558194, B568648, B622122, B622123, B638485, B638487, B644714, B645376, B647467, B649263, B652167, B652663, B654363, B655727, B683524, B703758, B704315, B704999, B710455, B729572, B730327, B785458, B785792, B785793, B807437, B809811; PED3-027-500-18/00847536036918/B797650; PED3-027-500-20/00847536031098, 00847536035607, 00847536036925/B326325, B331608, B341953, B354635, B370450, B377872, B381636, B386124, B396652, B416028, B426418, B443827, B456058, B457830, B466125, B472700, B476324, B479966, B485115, B566387, B590194, B596594, B603380, B645491, B645898, B645962, B647222, B650050, B651347, B677890, B678397, B678959, B679068, B684999, B695686, B705596, B705610, B707567, B707606, B717655, B727541, B734039, B737927, B737928, B752681, B763087, B772659, B773371, B773372, B779449, B779450, B779633; PED3-027-500-25/00847536031104, 00847536035614, 00847536036932/B354639, B382191, B387287, B396748, B413971, B417560, B472568, B478679, B536229, B570707, B603199, B646445, B648039, B680655, B688975, B689445, B693010, B694374, B695076, B700554, B702913, B720212, B720213, B720231, B747329, B747330, B747332, B751359, B761968, B763427, B800923; PED3-027-500-30/00847536031111, 00847536035621, 00847536036949/B337320, B342643, B358320, B378426, B382386, B382844, B401379, B427074, B428049, B428522, B429875, B435865, B436340, B445405, B452880, B456544, B596584, B598708, B606136, B623128, B655004, B655034, B655744, B663561, B666422, B668512, B669368, B669370, B707244, B728433, B743037, B743038, B743039, B750658, B751192, B752314, B752315, B779538; PED3-027-500-40/00847536031135, 00847536035645, 00847536036963/B319346, B340946, B373012, B373062, B374156, B379194, B397871, B398496, B456742, B457215, B464764, B467126, B473757, B482175, B567777, B573469, B585305, B590192, B677757, B682747, B693594, B701050, B703777, B703949, B707108, B710395, B711021, B711022, B736159, B747948, B749861, B753183, B753184, B762889, B773500; PED3-027-550-16/00847536031166, 00847536035683, 00847536037007/B358321, B369526, B452971, B497779, B575962, B580922, B622743, B623127, B686266, B689577, B707045, B707126, B708154, B708159, B720912, B720913, B739371, B749920, B782490, B806751; PED3-027-550-18/00847536037014/B803199; PED3-027-550-20/00847536035706, 00847536031180, 00847536037021/B412256, B417797, B446018, B454303, B496490, B560727, B565445, B578965, B615897, B623137, B623138, B690738, B691319, B692483, B695336, B713205, B713214, B717726, B731786, B731789, B740657, B741946, B764254, B764286, B766393, B766406, B780554, B781697, B800693, B808083; PED3-027-550-30/00847536031203, 00847536035720, 00847536037045/B397247, B408458, B414706, B416571, B473971, B475784, B479273, B494116, B608410, B611882, B615380, B663584, B666410, B695406, B696119, B697734, B709920, B713734, B713735, B729710, B738501, B738502, B746449, B783057, B783239, B783566; PED3-027-550-40/00847536031227, 00847536035744, 00847536037069/B358931, B378536, B389916, B409027, B433336, B437033, B454059, B493075, B494673, B612534, B615604, B616547, B652056, B654234, B655595, B671064, B672455, B672476, B684986, B704973, B706035, B707059, B717259, B717261, B742095, B750469, B761584, B768849, B771892, B771893, B773963, B778320, B778326, B780176; PED3-027-550-50/00847536031241, 00847536035768, 00847536037083/B397414, B412119, B431531, B435644, B437187, B616028, B637697, B658014, B705133, B717320, B717336, B717341, B724924, B745389, B745405, B745974, B749926, B785200, B785874; PED3-027-600-16/00847536031289, 00847536035805, 00847536037120/B368960, B454127, B603197, B607478, B611280, B611281, B690544, B691908, B693533, B709546, B720780, B732968, B762785, B801322; PED3-027-600-18/00847536037137/B801452; PED3-027-600-20/00847536031302, 00847536035829, 00847536037144/B317266, B338536, B376423, B412355, B446526, B491096, B596581, B608223, B624427, B624430, B681791, B682681, B698133, B701028, B708016, B708642, B709539, B713242, B720316, B720318, B747892, B747893, B761449, B769429, B805791; PED3-027-600-30/00847536031326, 00847536035843, 00847536037168/B339559, B412787, B457289, B467222, B489389, B594600, B597081, B611169, B611170, B626128, B652141, B653242, B654415, B681946, B682043, B701346, B711916, B712145, B719705, B726352, B726417, B728348, B735171, B748081, B748545, B748565, B758585, B808813; PED3-027-600-40/00847536031340, 00847536035867, 00847536037182/B320318, B337325, B360226, B369513, B379020, B419419, B480964, B485981, B485982, B549767, B552409, B559740, B567778, B608855, B618581, B622005, B655601, B655798, B669603, B694091, B695569, B699270, B711618, B716111, B720752, B721600, B742928, B745966, B758046, B758050, B760363, B767594, B790633, B800873; PED3-027-600-50/00847536031364, 00847536035881, 00847536037205/B327190, B332681, B342121, B403885, B415948, B428706, B429330, B433507, B434230, B457419, B557587, B617560, B623582, B626133, B651590, B652749, B653261, B653391, B658476, B658484, B670055, B670398, B673424, B680095, B695531, B703875, B713824, B714234, B726282, B732261, B732262, B732459, B733700, B746625, B758339, B758371, B768841, B783879, B783888, B788852, B790033, B794845	18,245
Z-1246-2025	Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2; Instructions for Use, Version: Rev. A (01/2024). REF/UDI-DI/Lot: PED3-021-350-16/00847536030701, 00847536035195, 00847536036529/B317460, B327449, B335184, B340948, B349032, B389162, B392918, B424454, B430015, B495821, B497938, B547396, B550307, B551615, B559033, B603377, B623564, B656863, B656887, B658904, B692346, B715057, B715058, B715541, B726894, B735821, B735823, B756029, B756030, B760210, B760211, B768202, B768387, B769453, B770633, B807494; PED3-021-250-14/00847536030411, 00847536034907, 00847536036239/B317936 B332767, B333492, B333536, B334545, B376967, B388041, B391185, B399354, B416713, B431395, B452416, B457963, B467691, B476239, B564173, B564970, B574472, B580923, B629372, B630998, B670305, B673035, B699576, B707568, B709193, B736698, B736893, B739090, B739091, B795110, B796586, B800827, B801770; PED3-021-350-20/00847536030725, 00847536035218, 00847536036543/B319436, B336571, B379993, B383427, B389708, B400103, B400599, B403612, B407062, B415211, B446722, B483987, B490972, B492403, B494049, B552487, B559741, B591782, B591864, B592074, B622656, B626023, B648708, B684905, B715692, B719565, B719567, B719659, B726923, B728926, B735667, B756330, B765053, B768231, B770237, B770248, B792630; PED3-021-250-20/00847536030442, 00847536034938, 00847536036260/B321465, B337378, B360749, B371070, B412868, B467843, B477487, B488713, B548244, B557602, B644034, B673388, B679822, B684208, B686727, B695486, B698571, B703035, B708080, B709204, B711078, B746067, B757056, B757060, B761030, B771498, B775215, B789892, B790055; PED3-021-300-16/00847536030541, 00847536035034, 00847536036369/B321725, B338497, B405720, B418200, B570723, B574473, B603375, B604477, B656277, B658580, B659806, B666425, B681289, B691752, B699606, B703209, B707982, B711365, B725679, B736659, B738114, B769551, B769582, B798864; PED3-021-300-20/00847536030565, 00847536035058, 00847536036383/B322263, B336066, B347327, B376257, B405892, B414535, B458672, B458776, B469040, B490920, B495292, B563197, B607500, B607501, B635214, B636992, B656299, B656355, B657960, B668529, B678482, B680045, B681190, B712110, B712111, B718522, B720923, B725457, B732895, B735956, B737156, B737367, B748272, B748683, B749541, B775230, B778774, B780044; PED3-021-275-12/00847536030466, 00847536034952, 00847536036284/B323044, B383016, B391275, B399486, B454385, B468406, B623580, B623583, B624424, B657776, B666498, B669520, B670179, B670226, B710976, B743820, B743822, B754659, B762034, B768199, B798851; PED3-021-275-16/00847536030480, 00847536034976, 00847536036307/B323046, B361987, B406342, B414102, B458076, B468915, B477868, B558538, B562688, B563304, B603078, B654235, B656399, B657059, B666486, B669610,B670343, B677246, B699308, B736874, B743098, B755194, B755196, B755673, B769461, B771317, B775167, B775168; PED3-021-325-12/00847536030602, 00847536035096, 00847536036420/B324297, B407597, B418843, B494876, B561787, B592073, B623579, B629046, B676507, B678997, B716220, B741395, B751748, B787015, B787017; PED3-021-325-14/00847536030619, 00847536035102, 00847536036437/B324809, B347993, B362685, B459598, B558177, B563209, B575964, B580901, B628946, B675724, B678948, B681904, B714342, B714344, B733352, B733353, B769593, B790478; PED3-021-325-16/00847536030626, 00847536035119, 00847536036444/B324954, B339033, B371691, B418451, B460439, B495941, B603378, B604475, B623578, B624422, B660509, B664402, B666503, B667510, B667920, B668523, B680717, B681747, B733912, B739722, B739723, B739724, B746618, B794191, B794192; PED3-021-325-20/00847536030640, 00847536035133, 00847536036468/B325613, B371743, B418905, B421650, B463895, B487451, B495368, B591952, B591955, B644630, B644769, B644809, B657857, B659135, B659138, B659243, B684852, B716733, B716735, B741305, B741316, B741321, B787131; PED3-021-250-12/00847536030404, 00847536034891, 00847536036222/B326236, B335270, B387931, B390988, B394283, B421249, B477292, B497244, B578963, B664457, B666521, B667945, B669726, B696189, B719158, B724199, B724200, B724764, B741102, B746521, B764797, B764798, B787764, B787765, B787766, B793905; PED3-021-300-14/00847536030534, 00847536035027, 00847536036352/B327828, B335957, B346789, B393640, B399293, B403772, B456576, B547554, B568649, B575299, B631125, B631126, B649258, B650123, B652886, B657773, B683152, B711496, B712157, B712158, B732804, B732807, B754755, B754756, B754757, B760951, B760953, B768142, B769947, B789256; PED3-021-250-16/00847536030428, 00847536034914, 00847536036246/B328095, B416673, B452284, B478579, B494048, B565441, B573470, B575302, B628868, B628869, B630965, B656206, B666535, B667323, B668743, B739139, B739405, B739408, B754155, B754886, B754888, B755651, B794406, B794408, B794426; PED3-021-300-12/00847536030527, 00847536035010, 00847536036345/B338969, B345449, B346121, B361988, B405158, B418358, B454923, B551608, B561782, B562698, B563303, B575894, B677108, B677319, B699289, B703245, B718483, B718491, B739905, B744728, B760716, B766588; PED3-021-275-14/00847536030473, 00847536034969, 00847536036291/B343142, B361366, B379727, B429213, B448933, B452378, B461124, B601345, B607550, B624425, B626121, B678023, B680119, B711192, B713287, B724745, B744169, B744175, B744176, B770971, B770988; PED3-021-350-14/00847536030695, 00847536035188, 00847536036512/B349031, B372357, B388981, B391924, B399969, B421758, B445867, B491603, B492310, B497318, B596593, B629649, B630549, B631109, B670495, B678371, B679957, B713023, B713796, B740630, B740631, B742526, B743935, B753618; PED3-021-350-25/00847536030732, 00847536035225, 00847536036550/B364361, B393438, B403082, B419021, B422233, B430531, B437842, B447224, B488266, B616574, B624414, B629444, B629660, B672265, B672892, B673364, B717131, B717132, B724110, B733587, B733590, B741976, B761681, B768780, B771211, B772034, B773456, B773457; PED3-021-350-12/00847536030688, 00847536035171, 00847536036505/B368529, B406425, B419491, B490325, B496666, B497114, B611908, B615889, B616569, B643508, B643509, B644619, B657109, B658427, B659171, B690687, B715610, B715612, B716621, B742378, B746455, B787264; PED3-021-250-10/00847536030398, 00847536036215, 00847536034884/B387475, B390553, B427939, B490270, B575123, B578342, B628755, B654233, B666402, B670376, B693553, B707945, B711113, B740699, B764024, B764025, B766116, B769419, B797931, B801945; PED3-021-275-20/00847536030503, 00847536034990, 00847536036321/B391792, B398628, B418296, B452832, B461730, B497830, B548241, B567772, B655966, B656945, B666505, B671729, B677211, B679094, B680758, B693403, B699179, B711385, B725638, B725639, B736012, B736612, B737225, B751998, B756411, B797986; PED3-021-350-18/00847536036536/B798906; PED3-021-325-18/00847536036451/B800239; PED3-021-275-18/00847536036314/B805162; PED3-021-250-18/00847536036253/B805488; PED3-021-300-18/00847536036376/B807417	7820

Based on the official FDA remedy

What to do — step by step

Check Product Reference
Identify the device reference code (REF) on the product label or documentation to confirm if it is recalled.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 46 states.

FDA distribution: “Worldwide distribution: US (nationwide): PR, OK, CA, MD, FL, NY, WA, MI, AL, NV, MN, NJ, IL, OH, AK, CT, TN, MO, TX, ID, AZ, WI, PA, OR, SD, VA, CO, GA, KY, IN, AR, MA, LA, NE, MT, ME, SC, DC, NC, ND, NM, IA, UT, KS, WV, NH, HI, RI. And…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

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

Jan 30, 2025Firm started the recall
Mar 5, 2025FDA classified it Class I
Mar 12, 2025Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Micro Therapeutics recalls

Link to this recall

<a href="https://govinfonow.com/recall/53011-medtronic-pipeline-vantage-embolization-device-with-shield-technology-recall-risk">Medtronic Pipeline Vantage Embolization Device with Shield Technology recall: Risk (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-1246-2025 (January 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1246-2025 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 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.