FDA Device recall Z-1941-2024
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions by Stryker Neurovascular, citing 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 guidewir….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1941-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-18 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker Neurovascular |
| Distribution | US |
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.
Identifiers
| code_info | Catalog/UDI-DI/Lots: M00326110/04546540688736/0000064108, 0000065017, 0000065616, 0000066470, 0000066581, 0000067561, 0…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, 00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1941-2024%22
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