Stryker Neurovascular recalls certain Synchro SELECT Guidewires with older introducer accessories that may cause PTFE coating damage when backloaded during use. Affected lots have sharper edges that can peel off the coating.
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 specific lots of Synchro SELECT Guidewires due to a risk of PTFE coating damage when physicians use a technique called backloading. This issue is limited to certain lots that came with older introducer accessories with sharper edges that may peel off the coating.
The older introducer accessories have edges that are sharper than intended. When physicians use backloading (pushing the guidewire through the introducer), these edges can peel off the PTFE coating, potentially causing damage to the guidewire during procedures.
Healthcare professionals using the Synchro SELECT Guidewires for neurovascular procedures are most at risk. Patients receiving these devices during procedures are not directly affected by the recall.
Check the lot numbers listed in the recall notice. The affected lots include specific combinations of product codes (e.g., SSFT215PRE, SSFT215STR) and lot numbers like 0000139994 or 0000144321.
Do not use backloading when inserting the guidewire through the older introducer accessory.
Stryker Neurovascular observed an increased frequency of PTFE coating damage on certain lots of Synchro SELECT Guidewires when backloading through older introducer accessories.
The risk is that the PTFE coating may peel off due to sharper edges on older introducer accessories, which could cause damage during procedures.
Check the lot numbers listed in the recall notice, which include specific combinations of product codes and lot numbers like 0000139994 or 0000144321.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1940-2024 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-1940-2024 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.
