FDA Device Recall Z-1245-2025

Device

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

Lot / serial / GTIN: 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

Quantity: 18,245

Reason for recall

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

Recall record

Recall number

Z-1245-2025

Classification

Class I

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

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 initiated

2025-01-30

Classified by FDA Center

2025-03-05

FDA published

2025-03-12

Recalling firm

Micro Therapeutics, Inc.

Firm location

Irvine, CA