Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with potential separation during procedures, risking stroke or complications. Affected units have specific lot numbers and UDI/DI codes.
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 due to a risk of separation during medical procedures, which could lead to stroke or other complications if not addressed. This affects specific units with known lot numbers and UDI/DI codes.
The system could separate during medical procedures if there's a delay or unplanned intervention, potentially causing stroke or other complications while waiting for a replacement device.
Medical professionals using the ANGIOGUARD RX/XP system during procedures are most at risk. Patients undergoing the procedure with affected devices may face complications.
Check for lot numbers starting with 35265661 and UDI/DI code 20705032056851 on the device packaging or labels. The product is sold under the brand name ANGIOGUARD RX/XP Emboli Capture Guidewire System.
Look for lot number 35265661 and UDI/DI code 20705032056851 on the device packaging or labels.
The product is not safe for use in the current configuration due to the risk of separation during procedures, which could lead to stroke or complications.
The official recall notice does not specify a remedy, so contact Cordis directly for guidance on next steps.
Check for lot number 35265661 and UDI/DI code 20705032056851 on the device packaging or labels.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1486-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1486-2023 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.
