Stryker Neurovascular recalls Synchro2 Guidewires with certain lots due to PTFE coating damage when backloading through older introducer accessories. Affected units have specific lot numbers listed in the 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.
Stryker Neurovascular is recalling certain lots of Synchro2 Guidewires because using a technique called backloading through older introducer accessories can damage the PTFE coating. This risk is limited to specific lot numbers and does not affect all units.
The PTFE coating on the guidewires can become damaged when physicians use a technique called backloading through older introducer accessories. This happens because the introducer accessories have sharper edges than intended, which can peel off the coating. Damaged coating may lead to complications during procedures.
Healthcare professionals using these guidewires for neurovascular procedures are most at risk. Patients with impacted product in their inventory should avoid backloading the guidewire through the older introducer accessory.
Check the lot numbers listed in the recall (e.g., M00326110, 0000064108, etc.) on the product packaging. The Synchro2 Guidewires are steerable guidewires with a shapeable tip used in neurovascular procedures.
Users with impacted product in their inventory should not use backloading through the older introducer accessory.
The PTFE coating can be damaged when backloading through older introducer accessories due to sharper edges on the introducer, which may peel off the coating.
Affected lots include M00326110/04546540688736/0000064108, 0000065017, and other specific lot numbers listed in the recall.
The recall does not mention a return requirement; users should avoid backloading through the older introducer accessory.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1941-2024 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-1941-2024 from Stryker Neurovascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
