Recall archive / FDA device enforcement

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-02... — FDA record Z-1246-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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: 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
Classification: Class I
Recalling firm: Micro Therapeutics, Inc.
Quantity: 7820
Agency-reported status: Ongoing
Source record identifier: Z-1246-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Label field

Details supplied by the agency

Lot, code or applicability

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

Match all identifying details in the current notice. A brand name alone is not enough.

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 12, 2025
Recall initiation date: Jan 30, 2025
Center classification date: Mar 5, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records