Reported Mar 12, 2025 · Ongoing

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14,…

Micro Therapeutics, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Micro Therapeutics, Inc. · 9775 Toledo Way · Irvine, CA · 92618-1811

Is this the product you have?

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
PartM056989CDOC2

Lot codes and dates: 27 of 27 products
Products covered by this recall
# Barcodes Product as published
1 008475360307010084753603519500847536036529 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
2 008475360304110084753603490700847536036239 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
3 008475360307250084753603521800847536036543 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
4 008475360304420084753603493800847536036260 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
5 008475360305410084753603503400847536036369 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
6 008475360305650084753603505800847536036383 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
7 008475360304660084753603495200847536036284 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
8 008475360304800084753603497600847536036307 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
9 008475360306020084753603509600847536036420 PED3-021-325-12/00847536030602, 00847536035096, 00847536036420/B324297, B407597, B418843, B494876, B561787, B592073, B623579, B629046, B676507, B678997, B716220, B741395, B751748, B787015, B787017
10 008475360306190084753603510200847536036437 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
11 008475360306260084753603511900847536036444 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
12 008475360306400084753603513300847536036468 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
13 008475360304040084753603489100847536036222 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
14 008475360305340084753603502700847536036352 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
15 008475360304280084753603491400847536036246 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
16 008475360305270084753603501000847536036345 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
17 008475360304730084753603496900847536036291 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
18 008475360306950084753603518800847536036512 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
19 008475360307320084753603522500847536036550 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
20 008475360306880084753603517100847536036505 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
Page 1 of 2
Amount recalled: 7820

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Medtronic Pipeline Vantage Embolization Device with Shield Technology

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`008475360307010084753603519500847536036529`	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
2	`008475360304110084753603490700847536036239`	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
3	`008475360307250084753603521800847536036543`	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
4	`008475360304420084753603493800847536036260`	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
5	`008475360305410084753603503400847536036369`	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
6	`008475360305650084753603505800847536036383`	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
7	`008475360304660084753603495200847536036284`	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
8	`008475360304800084753603497600847536036307`	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
9	`008475360306020084753603509600847536036420`	PED3-021-325-12/00847536030602, 00847536035096, 00847536036420/B324297, B407597, B418843, B494876, B561787, B592073, B623579, B629046, B676507, B678997, B716220, B741395, B751748, B787015, B787017
10	`008475360306190084753603510200847536036437`	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
11	`008475360306260084753603511900847536036444`	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
12	`008475360306400084753603513300847536036468`	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
13	`008475360304040084753603489100847536036222`	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
14	`008475360305340084753603502700847536036352`	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
15	`008475360304280084753603491400847536036246`	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
16	`008475360305270084753603501000847536036345`	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
17	`008475360304730084753603496900847536036291`	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
18	`008475360306950084753603518800847536036512`	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
19	`008475360307320084753603522500847536036550`	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
20	`008475360306880084753603517100847536036505`	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