Reported Mar 12, 2025 · Ongoing

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14,…

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
- PED3-027-350-12
- 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 codes and dates: 39 of 39 products
Products covered by this recall
# Barcodes Product as published
1 0084753603526300847536030770 All unused devices. Product lots including and between B317266 and B817292. REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548
2 0084753603528700847536030787 PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880
3 0084753603529400847536030794 PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808
4 0084753603531700847536030817 PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630
5 0084753603532400847536030824 PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938
6 008475360308620084753603536200847536036680 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
7 008475360308790084753603537900847536036697 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
8 008475360308860084753603538600847536036703 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
9 00847536036710 PED3-027-400-18/00847536036710/B795091
10 008475360309090084753603540900847536036727 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
11 008475360309160084753603541600847536036734 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
12 008475360309230084753603542300847536036741 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
13 008475360309610084753603546100847536036789 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
14 008475360309780084753603547800847536036796 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
15 008475360309850084753603548500847536036802 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
16 00847536036819 PED3-027-450-18/00847536036819/B797308
17 008475360310050084753603550800847536036826 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
18 008475360310120084753603551500847536036833 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
19 008475360310290084753603552200847536036840 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
20 008475360310430084753603554600847536036864 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
Page 1 of 2
Amount recalled: 18,245

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	`0084753603526300847536030770`	All unused devices. Product lots including and between B317266 and B817292. REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548
2	`0084753603528700847536030787`	PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880
3	`0084753603529400847536030794`	PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808
4	`0084753603531700847536030817`	PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630
5	`0084753603532400847536030824`	PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938
6	`008475360308620084753603536200847536036680`	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
7	`008475360308790084753603537900847536036697`	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
8	`008475360308860084753603538600847536036703`	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
9	`00847536036710`	PED3-027-400-18/00847536036710/B795091
10	`008475360309090084753603540900847536036727`	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
11	`008475360309160084753603541600847536036734`	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
12	`008475360309230084753603542300847536036741`	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
13	`008475360309610084753603546100847536036789`	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
14	`008475360309780084753603547800847536036796`	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
15	`008475360309850084753603548500847536036802`	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
16	`00847536036819`	PED3-027-450-18/00847536036819/B797308
17	`008475360310050084753603550800847536036826`	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
18	`008475360310120084753603551500847536036833`	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
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