Class 2 Device Recall Synchro 10 and 14 Guidewire

• Date Initiated by Firm: April 18, 2024
• Date Posted: May 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1939-2024
• Recall Event ID: 94543
• 510(K)Number: K032146
• Product Classification: Wire, guide, catheter - Product Code DQX
• Product: The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.014in. 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. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.
• Code Information: Catalog/UDI-DI/Lots: M00316310/07613252187158/0000131357, 0000132153, 0000132740, 0000135026, 0000138147, 0000138148, 0000138579, 0000142533, 0000144961, 0000145874, 0000154419, 0000156324, 0000156614, 0000158907, 0000158911, 0000164603, 0000173346, 0000173701, 0000173702, 0000173771, 0000173995; M00316330/07613252187165/0000142692, 0000158995; M00313010/07613252186922/0000129027, 0000129028, 0000129029, 0000129218, 0000129219, 0000129630, 0000129631, 0000129841, 0000129842, 0000129902, 0000130225, 0000130226, 0000130410, 0000130411, 0000130412, 0000130502, 0000130503, 0000130643, 0000130645, 0000130869, 0000130870, 0000131304, 0000131307, 0000131343, 0000131724, 0000131725, 0000131726, 0000132154, 0000132155, 0000132582, 0000132640, 0000132641, 0000133182, 0000133183, 0000133391, 0000133565, 0000133566, 0000133567, 0000133568, 0000133928, 0000133929, 0000134128, 0000134129, 0000134130, 0000134307, 0000134308, 0000135009, 0000135148, 0000135149, 0000135303, 0000135304, 0000135806, 0000135807, 0000136252, 0000136923, 0000137267, 0000137322, 0000137373, 0000137374, 0000137375, 0000138751, 0000139437, 0000141635, 0000142248, 0000142249, 0000142541, 0000142691, 0000143123, 0000143350, 0000143351, 0000143585, 0000143955, 0000144141, 0000144320, 0000144379, 0000144380, 0000144739, 0000144760, 0000144761, 0000144764, 0000144959, 0000144960, 0000145884, 0000145885, 0000146228, 0000146390, 0000146515, 0000146843, 0000146916, 0000147040, 0000147186, 0000147306, 0000147440, 0000147585, 0000147876, 0000148965, 0000149562, 0000150095, 0000150872, 0000150873, 0000151381, 0000151461, 0000151677, 0000151847, 0000151848, 0000152230, 0000152231, 0000152375, 0000152522, 0000152977, 0000153282, 0000153370, 0000153970, 0000154140, 0000154302, 0000154303, 0000154779, 0000154780, 0000154894, 0000154895, 0000155020, 0000155068, 0000156317, 0000156321, 0000156615, 0000156626, 0000156794, 0000156800, 0000157226, 0000157227, 0000157892, 0000157894, 0000158127, 0000158128, 0000158131, 0000158339, 0000158340, 0000159324, 0000159932, 0000159997, 0000159998, 0000160368, 0000160369, 0000160434, 0000160435, 0000160893, 0000160894, 0000160895, 0000161061, 0000161062, 0000161063, 0000162104, 0000162105, 0000162106, 0000162896, 0000162991, 0000162992, 0000163716, 0000163967, 0000163968, 0000164443, 0000164470, 0000165356, 0000165363, 0000165364, 0000166540, 0000166542, 0000166544, 0000170149, 0000170246, 0000170940, 0000171065, 0000171235, 0000172266, 0000172267, 0000172381, 0000172787, 0000172865, 0000172866, 0000173279, 0000174292, 0000174373, 0000174380, 0000174409, 0000174680, 0000174681, 0000175067, 0000175068, 0000175069, 0000175640, 0000175641, 0000175983, 0000175984, 0000175985, 0000175986, 0000176344, 0000176345, 0000176504, 0000176523, 0000176830, 0000176836, 0000177535, 0000178075, 0000178076, 0000178532, 0000178533, 0000178535, 0000178626, 0000179628, 0000179629, 0000180361, 0000180738, 0000180800, 0000193546; M00313020/07613252186939/0000159372, 0000172593; M00313310/07613252186946/0000135007, 0000135008, 0000136409, 0000136410,0000136679, 0000139937, 0000139938, 0000140307, 0000140689, 0000140690, 0000141634, 0000141833, 0000142246, 0000152799, 0000153160, 0000153453, 0000153968, 0000153969, 0000154301, 0000157222, 0000157223, 0000157224, 0000159320, 0000159370, 0000160740, 0000172380, 0000172594, 0000172619, 0000172661, 0000172662, 0000172748, 0000172786, 0000176476, 0000176840, 0000176841, 0000177540, 0000178232, 0000180657, 0000180737, 0000180795; M00313410/07613252186960/0000173997
• 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.
• FDA Determined Cause: Component design/selection
• 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.
• Quantity in Commerce: 105,286
• 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.
• Total Product Life Cycle: TPLC Device Report

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.

• 510(K) Database: 510(K)s with Product Code = DQX