| | Class 2 Device Recall Synchro2 Guidewire |  |
| Date Initiated by Firm | April 18, 2024 |
|---|
| Date Posted | May 31, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1941-2024 |
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| Recall Event ID |
94543 |
| 510(K)Number | K053268 |
|---|
| Product Classification |
Wire, guide, catheter - Product Code DQX
|
| 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. |
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| Code Information |
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;
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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
|
| FEI Number |
3008853977
|
Recalling Firm/
Manufacturer |
Stryker Neurovascular
47900 Bayside Pkwy
Fremont CA 94538-6515
|
Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Component design/selection |
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| Action | 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. |
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| Quantity in Commerce | 373,246 |
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| 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.
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DQX
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