The Synchro Neuro Guidewires are a steerable guidewire family with a… — Class II medical device recall Z-1939-2024
Ongoing recall by Stryker Neurovascular, reported 2024-06-12, distributed nationwide. Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guid
| Recall number | Z-1939-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Neurovascular, Fremont, CA, United States |
| Recall initiated | 2024-04-18 |
| Classified | 2024-05-31 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CN, CO, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IS, JO, JP, KR, KW, LT, LU, MX, NL, NO, PH, PL, PT, RO, RU, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 105,286 |
| UPC / GTIN / UDI-DI | 07613252186922, 07613252186939, 07613252186946, 07613252186960, 07613252187158, 07613252187165 |
| Lot numbers | 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, 0000132153, 0000132154, 0000132155, 0000132582, 0000132640, 0000132641, 0000132740, 0000133182, 0000133183, 0000133391, 0000133565, 0000133566, 0000133567, 0000133568 and 234 more |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1939-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.