Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with specific lot numbers due to potential separation during medical procedures, which could lead to stroke or other complications.
There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared.
Cordis is recalling ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with specific lot numbers because they might separate during medical procedures, potentially causing stroke or other complications. This is a serious risk for patients undergoing certain surgeries.
The device could separate during medical procedures if there's a delay, unplanned surgery, or other interventions. This separation might cause a stroke or other complications if a replacement device isn't immediately available.
Patients undergoing procedures involving the ANGIOGUARD system are most at risk, particularly those with specific lot numbers. Healthcare providers using the device in surgeries may also be affected.
Check the lot numbers on the device: 35265335 or 35264202. The product is identified by the reference number 801814RMC and UDI/DI 20705032056943.
Look for lot numbers 35265335 or 35264202 on the ANGIOGUARD RX/XP Emboli Capture Guidewire System.
The device could separate during medical procedures, potentially causing stroke or other complications if a replacement isn't immediately available.
Check the lot numbers: 35265335 or 35264202. The product is identified by reference number 801814RMC and UDI/DI 20705032056943.
The recall record does not specify a remedy, so contact Cordis directly for guidance.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1487-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1487-2023 from Cordis. 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.
