—#207544

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.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K053268
Affected lot / code info: 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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0000128620, 0000129206, 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, 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, 0000094935, 0000095077, 0000095424, 0000095426, 0000095429, 0000095475, 0000095836, 0000095874, 0000096624, 0000096629, 0000096630, 0000096631, 0000096772, 0000096914, 0000097107, 0000097108, 0000097505, 0000097695, 0000097696, 0000097784, 0000097841, 0000097842, 0000099524, 0000099527, 0000099660, 0000100303, 0000100602, 0000100988, 0000101377, 0000101378, 0000101621, 0000101622, 0000101651, 0000102589, 0000102793, 0000102794, 0000102795, 0000102796, 0000103037, 0000103809, 0000104202, 0000104524, 0000104574, 0000104973, 0000104974, 0000105253, 0000105351, 0000105763, 0000105956, 0000105957, 0000106028, 0000106405, 0000106411, 0000106412, 0000107495, 0000107934, 0000107935, 0000108145, 0000108433, 0000108813, 0000109901, 0000110233, 0000110879, 0000110880, 0000111101 ,0000111453, 0000112240, 0000112285, 0000112709, 0000112822, 0000112823, 0000112844, 0000113136, 0000113690, 0000113790, 0000113791, 0000114166, 0000114167, 0000114170, 0000115255, 0000115598, 0000115599, 0000115668 ,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, 0000133846, 0000133847, 0000133931, 0000133932, 0000134092, 0000134093, 0000136250, 0000136251, 0000136411, 0000136412, 0000136676, 0000136677, 0000136918, 0000136919, 0000136922, 0000137320, 0000137321, 0000138750, 0000140167, 0000140175, 0000140308, 0000140564, 0000140568, 0000140977, 0000141439, 0000141440, 0000141441, 0000144374, 0000144831, 0000144832, 0000145094, 0000147187, 0000147188, 0000147383, 0000147438, 0000147439, 0000147588, 0000147983, 0000147984, 0000148347, 0000148348, 0000148349, 0000148350, 0000148351, 0000148889, 0000148892, 0000148963, 0000149417, 0000149418, 0000150098, 0000151282, 0000151283, 0000151284, 0000151382, 0000151383, 0000151679, 0000151849, 0000152229, 0000152374, 0000152519, 0000152520, 0000152521, 0000152800, 0000153607, 0000153694, 0000153695, 0000153972, 0000153984, 0000154307, 0000154308, 0000155015, 0000155066, 0000155069, 0000155663, 0000155664, 0000156793, 0000157431, 0000157433, 0000157434, 0000157890, 0000157891, 0000158805, 0000158806, 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; S2SPS14215/07613327459630/0000064656, 0000065327, 0000065644, 0000067080, 0000067171, 0000067663, 0000068249, 0000072389, 0000084516, 0000084517, 0000091104, 0000095875, 0000100603, 0000103807, 0000109593, 0000113421, 0000114789, 0000118119, 0000121583, 0000122737, 0000125039, 0000126355, 0000128621, 0000139101, 0000141394, 0000143124, 0000143346, 0000147308, 0000176835; S2SPS14300/07613327459647/0000065435, 0000084518, 0000094339, 0000118540, 0000128617, 0000140967, 0000146841

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

On 4/29/24, recall notices were mailed to Supply Chain Management/ Recall Coordinator/ Inventory Manager customers who were asked to do the following: 1) When using impacted guidewires, please do not backload the guidewire, follow the Instructions for Use (IFU) provided with the device, and do not use the guidewire if you see any visible signs of coating damage. 2) Circulate this customer notification internally to all interested/affected parties. 3) Inform firm if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that the firm can inform the recipients appropriately. 4) Inform firm of any adverse events concerning the use of the subject devices. (US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com) 5) Complete and return the customer response form via email to: nvfieldactions@stryker.com. 6) Contact the firm if you would like a replacement of the guidewire with a new optional introducer accessory.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2024-04-18
Posted by FDA: 2024-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.