Recall archive / FDA device enforcement

The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-s... — FDA record Z-1941-2024

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 Apr 18, 2024. 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: The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque.
Reason: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.
Classification: Class II
Recalling firm: Stryker Neurovascular
Quantity: 373,246
Agency-reported status: Ongoing
Source record identifier: Z-1941-2024

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	Catalog/UDI-DI/Lots: M00326110/04546540688736/0000064108, 0000065017, 0000065616, 0000066470, 0000066581, 0000067561, 0000067801, 0000068246, 0000069276, 0000071094, 0000071841, 0000073548, 0000075207, 0000077751, 0000078371, 0000078837, 0000080548, 0000080988, 0000082965, 0000083195, 0000086130, 0000088254, 0000092394, 0000092395, 0000092396, 0000095029, 0000097492, 0000098543, 0000104203, 0000111901, 0000122898, 0000123072, 0000123529, 0000126054, 0000126497, 0000126852, 0000134099, 0000135605, 0000135804, 0000144373, 0000145738, 0000145739, 0000146146, 0000146147, 0000150989, 0000153606, 0000162889, 0000162890, 0000162891, 0000172273, 0000174770, 0000175634, 0000175636, 0000175637; M00326320/04546540688750/0000105764, 0000109900, 0000181399; M00326010/04546540688729/0000063878, 0000063985, 0000064269, 0000064281, 0000064309, 0000064357, 0000064360, 0000064370, 0000064796, 0000065004, 0000065161, 0000065227, 0000065269, 0000065449, 0000065450, 0000065733, 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0000086337, 0000087870, 0000087871, 0000087872, 0000088367, 0000088651, 0000088652, 0000090311, 0000091480, 0000091715, 0000092004, 0000092839, 0000093332, 0000093534, 0000094776, 0000094818, 0000095080, 0000095172, 0000096911, 0000096912, 0000097447, 0000097951, 0000098059, 0000099701, 0000099702, 0000099953, 0000100863, 0000100925, 0000100986, 0000102835, 0000102934, 0000103038, 0000103039, 0000104204, 0000104522, 0000104523, 0000106631, 0000106632, 0000106718, 0000107496, 0000107498, 0000108264, 0000108487, 0000109375, 0000109781, 0000109782, 0000109899, 0000111454, 0000111900, 0000112880, 0000112881, 0000113135, 0000113476, 0000113477, 0000113681, 0000114843, 0000114844, 0000114845, 0000115168, 0000116702, 0000116703, 0000117042, 0000117043, 0000121693, 0000121695, 0000122112, 0000122257, 0000122470, 0000123530, 0000123902, 0000123982, 0000123984, 0000125041, 0000125147, 0000125714, 0000125715, 0000126047, 0000126048, 0000126049, 0000126496, 0000128252, 0000128618, 0000128619, 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M00326520/04546540688798/0000066684, 0000073892, 0000090098, 0000105762, 0000122738, 0000151278; M00326410/04546540688767/0000063497, 0000063501, 0000063520, 0000063568, 0000063716, 0000063767, 0000063879, 0000063894, 0000063905, 0000063933, 0000064072, 0000064113, 0000064410, 0000064420, 0000064482, 0000064486, 0000064487, 0000064527, 0000064565, 0000064589, 0000064590, 0000064735, 0000064736, 0000064797, 0000064882, 0000064927,0000064960,0000064961, 0000065005, 0000065107, 0000065118, 0000065281, 0000065370, 0000065515, 0000065571, 0000065583, 0000065643, 0000065761, 0000065820, 0000065837, 0000065900, 0000066008, 0000066075, 0000066130, 0000066262, 0000066384, 0000066385, 0000066471,0000066552, 0000066644, 0000066824, 0000066962, 0000067082, 0000067170, 0000067332, 0000067456, 0000067567, 0000067653, 0000067654, 0000067711, 0000067712, 0000067829, 0000068248, 0000068627, 0000069225, 0000069730, 0000069790, 0000069919, 0000070220, 0000070221, 0000070423, 0000070424, 0000070640, 0000070641, 0000071095, 0000071096, 0000071378, 0000072028, 0000072029, 0000072244, 0000072277, 0000073133, 0000073549, 0000073550, 0000074431, 0000074451, 0000075208, 0000075209, 0000075553, 0000075554, 0000075915, 0000076455, 0000077386, 0000077387, 0000077389, 0000077554, 0000077555, 0000078272, 0000078273, 0000078372, 0000079396, 0000080021, 0000080914, 0000081395, 0000081697, 0000081741, 0000081742, 0000082781, 0000082985, 0000082986, 0000083855, 0000083856, 0000085274, 0000085367, 0000085368, 0000085369, 0000085635, 0000085636, 0000085724, 0000085952, 0000086425, 0000086538, 0000086539, 0000086540, 0000086939, 0000086940, 0000087549, 0000087550, 0000087582, 0000087635, 0000088255, 0000088811, 0000088890, 0000089000, 0000089068, 0000089069, 0000089523, 0000090313, 0000090391, 0000090548, 0000090549, 0000091107, 0000091372, 0000091477, 0000091478, 0000091479, 0000092564, 0000092594, 0000092702, 0000092838, 0000093535, 0000093536, 0000094533, 0000094737, 0000094742, 0000094931, 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,0000115669, 0000115670, 0000115926, 0000115927, 0000115965, 0000115966, 0000117044, 0000117679, 0000117830, 0000117831, 0000118137, 0000118138, 0000118202, 0000118415, 0000118416, 0000118675, 0000118804, 0000119600, 0000119601, 0000120211, 0000121051, 0000121106, 0000121215, 0000121216, 0000123073, 0000123148, 0000123149, 0000123406, 0000123493, 0000123526, 0000123527, 0000123983, 0000124070, 0000124158, 0000124159, 0000124212, 0000124213, 0000124629, 0000124630, 0000124637, 0000124638, 0000124846, 0000124847, 0000124848, 0000125413, 0000125417, 0000125696, 0000125717, 0000125718, 0000125788, 0000125789, 0000126853, 0000126923, 0000126924, 0000127370, 0000127371, 0000127750, 0000127751, 0000128386, 0000128387, 0000128524, 0000129626, 0000129628, 0000129839, 0000129840, 0000129900, 0000129901, 0000131302, 0000131303, 0000131335, 0000131336, 0000131720, 0000131721, 0000131722, 0000132105, 0000132106, 0000132107, 0000132150, 0000132151, 0000132152, 0000132739, 0000133393, 0000133394, 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0000159540, 0000159993, 0000159995, 0000160373, 0000160380, 0000160381, 0000160432, 0000161017, 0000163717, 0000164441, 0000164660, 0000164661, 0000165475, 0000169345, 0000169346, 0000170245, 0000171218, 0000171219, 0000172527, 0000172529, 0000172530, 0000172863, 0000172864, 0000173164, 0000173935, 0000173936, 0000173937, 0000174288, 0000174291, 0000174352, 0000174353, 0000174372, 0000174404, 0000174405, 0000174406, 0000174407, 0000174408, 0000176115, 0000176117, 0000176118, 0000176329, 0000176330, 0000176827, 0000176828, 0000176829, 0000177034, 0000177035, 0000177078, 0000177079, 0000177080, 0000177521, 0000177527, 0000177533, 0000180797, 0000180798; M00326510/04546540688781/0000063768, 0000063886, 0000064191, 0000064640, 0000065066, 0000066131, 0000066729, 0000066911, 0000067656, 0000067658, 0000067683, 0000068097, 0000069226, 0000069386, 0000069867, 0000070229, 0000070642, 0000071089, 0000073894, 0000074671, 0000075916, 0000077169, 0000077170, 0000078109, 0000079633, 0000081204, 0000081875, 0000081920, 0000082489, 0000083953, 0000084100, 0000086865, 0000087972, 0000089737, 0000090550, 0000091906, 0000093819, 0000094029, 0000094030, 0000097109, 0000097917, 0000099212, 0000101833, 0000102061, 0000103708, 0000105594, 0000107290, 0000109972, 0000111203, 0000111220, 0000114545, 0000116312, 0000116339, 0000118803, 0000118885, 0000121401, 0000121582, 0000121918, 0000124886, 0000126024, 0000126027, 0000134094, 0000135305, 0000139099, 0000139100, 0000142534, 0000146227, 0000146388, 0000146389, 0000146508, 0000146509, 0000150094, 0000150870, 0000152518, 0000152979, 0000153296, 0000153309, 0000156613, 0000157730, 0000158801, 0000160739, 0000163715, 0000164565, 0000170923, 0000170924, 0000170925, 0000173347, 0000173348, 0000173676, 0000173677, 0000174158, 0000174374, 0000175063, 0000177059, 0000177060, 0000177066; S2SPP14215/07613327459654/0000064643, 0000065728, 0000066913, 0000067173, 0000078582, 0000084347, 0000092593, 0000097916, 0000108963, 0000121105, 0000139102, 0000141827, 0000144378, 0000146510, 0000164584; S2SPP14300/07613327459661/0000084348; S2SP...

Label field

Details supplied by the agency

Lot, code or applicability

Catalog/UDI-DI/Lots: M00326110/04546540688736/0000064108, 0000065017, 0000065616, 0000066470, 0000066581, 0000067561, 0000067801, 0000068246, 0000069276, 0000071094, 0000071841, 0000073548, 0000075207, 0000077751, 0000078371, 0000078837, 0000080548, 0000080988, 0000082965, 0000083195, 0000086130, 0000088254, 0000092394, 0000092395, 0000092396, 0000095029, 0000097492, 0000098543, 0000104203, 0000111901, 0000122898, 0000123072, 0000123529, 0000126054, 0000126497, 0000126852, 0000134099, 0000135605, 0000135804, 0000144373, 0000145738, 0000145739, 0000146146, 0000146147, 0000150989, 0000153606, 0000162889, 0000162890, 0000162891, 0000172273, 0000174770, 0000175634, 0000175636, 0000175637; M00326320/04546540688750/0000105764, 0000109900, 0000181399; M00326010/04546540688729/0000063878, 0000063985, 0000064269, 0000064281, 0000064309, 0000064357, 0000064360, 0000064370, 0000064796, 0000065004, 0000065161, 0000065227, 0000065269, 0000065449, 0000065450, 0000065733, 0000065760, 0000065781, 0000065819, 0000065891, 0000066007, 0000066076, 0000066129, 0000066311, 0000066337, 0000066383, 0000066490, 0000066583, 0000066931, 0000066988, 0000067168, 0000067331, 0000067453, 0000067466, 0000067566, 0000067655, 0000067710, 0000067762, 0000067898, 0000068187, 0000068245, 0000068428, 0000068556, 0000069385, 0000069506, 0000069549, 0000069573, 0000069755, 0000069788, 0000069918, 0000070038, 0000070039, 0000070422, 0000070863, 0000071213, 0000071374, 0000071375, 0000071839, 0000071840, 0000073408, 0000073409, 0000073514, 0000073888, 0000074665, 0000074666, 0000074951, 0000074952, 0000075877, 0000076063, 0000076064, 0000076161, 0000076162, 0000076379, 0000076454, 0000077608, 0000077609, 0000077610, 0000078110, 0000078111, 0000078271, 0000078369, 0000078877, 0000078902, 0000080915, 0000080987, 0000081397, 0000081454, 0000081670, 0000082734, 0000082735, 0000084656, 0000084657, 0000084861, 0000084864, 0000085365, 0000085953, 0000086129, 0000086175, 0000086200, 0000086337, 0000087870, 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0000129207, 0000130642, 0000130824, 0000130864, 0000130865, 0000132955, 0000133180, 0000133181, 0000134097, 0000134098, 0000137241, 0000137242, 0000138582, 0000138583, 0000139438, 0000139439, 0000139440, 0000139441, 0000140683, 0000140685, 0000140686, 0000140687, 0000146927, 0000146928, 0000147307, 0000150096, 0000150097, 0000150879, 0000150880, 0000150988, 0000152801, 0000152802, 0000152978, 0000153316, 0000153369, 0000157899, 0000158129, 0000158130, 0000158341, 0000158800, 0000159841, 0000159842, 0000161219, 0000161220, 0000162107, 0000162894, 0000166350, 0000166351, 0000166352, 0000166353, 0000170244, 0000172271, 0000172272, 0000172302, 0000172304, 0000172599, 0000172600, 0000172620, 0000172621, 0000173240, 0000173242, 0000174284, 0000174287, 0000174768, 0000174769, 0000175639, 0000175710, 0000175750, 0000176474, 0000176475, 0000176833, 0000176834, 0000177999, 0000178005, 0000180681; M00326310/04546540688743/0000065570, 0000067169, 0000068247, 0000079906, 0000090099, 0000094378, 0000100182, 0000108962, 0000116675, 0000118886, 0000128525, 0000135805, 0000147879, 0000147987, 0000157735, 0000157736; M00326420/04546540688774/0000063779, 0000064566, 0000065241, 0000065646, 0000065762, 0000066263, 0000066472, 0000066582, 0000066989, 0000068096, 0000070222, 0000070864, 0000072031, 0000073134, 0000076285, 0000077556, 0000079694, 0000080326, 0000080455, 0000081868, 0000083175, 0000083952, 0000084099, 0000085613, 0000089328, 0000090670, 0000091905, 0000093818, 0000094819, 0000096587, 0000097110, 0000098541, 0000101652, 0000103036, 0000108815, 0000108961, 0000109973, 0000111204, 0000114401, 0000116311, 0000118674, 0000121398, 0000122490, 0000124885, 0000125790,0000135316, 0000135604, 0000138236, 0000138237, 0000141438, 0000147437, 0000147587, 0000148962, 0000148964, 0000151850, 0000152226, 0000155067, 0000155661, 0000161018, 0000163156, 0000172923, 0000172924, 0000174675, 0000176017, 0000176114, 0000176473, 0000176525; M00326520/04546540688798/0000066684, 0000073892, 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S2SPP14300/07613327459661/0000084348; S2SP...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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

Distribution

Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.

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: Jun 12, 2024
Recall initiation date: Apr 18, 2024
Center classification date: May 31, 2024

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

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