Home / Recalls / Micro Therapeutics, Inc. / Z-1246-2025

Z-1246-2025 Class I Ongoing

Recalled by Micro Therapeutics, Inc. — Irvine, CA

Recall Details

Product Type
Devices
Report Date
March 12, 2025
Initiation Date
January 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7820

Product Description

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

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

Distribution Pattern

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

Code Information

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

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  • Z-1557-2022 Class II — Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only (June 30, 2022)
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