Stryker Neurovascular has recalled approximately 519,606 Synchro, Synchro SELECT, and Synchro2 Neuro Guidewires due to a manufacturing defect in an included accessory. The introducer accessory in certain lots was found to have edges that are sharper than intended, which can scrape or peel off the wire's protective PTFE (Teflon) coating during use. This issue is particularly frequent when medical professionals use a technique called 'backloading' the guidewire through the introducer.
If the PTFE coating peels off the guidewire, it can release plastic debris into the patient's bloodstream, potentially causing blood clots, stroke, or vessel blockage. No specific injuries were detailed in this notification, but the manufacturer is cautioning users against the backloading technique with affected product lots.
Advisory for Inventory Users
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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