Stryker recalls certain Synchro Neuro Guidewires with PTFE coating damage risk when backloaded through older introducer accessories. Affected lots include specific serial 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 is recalling certain Synchro Neuro Guidewires that may have PTFE coating damage if used with older introducer accessories through a technique called backloading. This could lead to coating peeling off during procedures.
The PTFE coating on the guidewire tip can peel off when physicians use backloading (pushing the guidewire through the introducer accessory) with older versions of the introducer accessory that have sharper edges than intended. This peeling could cause complications during procedures.
Healthcare professionals using these guidewires in neurovascular procedures are most at risk. Patients receiving these guidewires during procedures may be affected if the coating damage occurs.
Check the lot numbers listed in the recall: M00316310/07613252187158/0000131357, 0000132153, 0000132740, 0000135026, 0000138147, 0000138148, 0000138579, 0000142533, 0000144961, 0000145874, 0000154419, 0000156324, 0000156614, 0000158907, 0000158911, 0000164603, 0000173346, 0000173701, 0000173702, 0000173771, 0000173995 and other specific serial numbers listed in the recall.
If you use backloading techniques with the guidewire, stop using this technique with affected lots to prevent PTFE coating damage.
The PTFE coating may peel off when backloading through older introducer accessories, which could lead to complications during procedures.
Check the lot numbers listed in the recall: M00316310/07613252187158/0000131357, 0000132153, 0000132740, 0000135026, 0000138147, 0000138148, 0000138579, 0000142533, 0000144961, 0000145874, 0000154419, 0000156324, 0000156614, 0000158907, 0000158911, 0000164603, 0000173346, 0000173701, 0000173702, 0000173771, 0000173995 and other specific serial numbers listed in the recall.
The recall does not require returning the product; healthcare professionals are advised to stop using backloading with affected lots.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1939-2024 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1939-2024 from Stryker. 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.
