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 certain lot numbers because they might separate during medical procedures, potentially causing stroke or other complications. This affects patients undergoing procedures that use these devices.
The device parts could separate during medical procedures if there's a delay or unplanned intervention, which might cause a stroke or other complications. This separation risk occurs when the device is being used in procedures that require quick adjustments.
Patients using the ANGIOGUARD RX/XP Emboli Capture Guidewire System for medical procedures are most at risk. The recall applies to specific lot numbers sold to hospitals and clinics.
Check the lot numbers on the device: 35264219, 35265391, 35265392, 35265399, 35265668, 35265660. The product is sold under the brand Cordis for medical procedures.
Look for lot numbers 35264219, 35265391, 35265392, 35265399, 35265668, or 35265660 on the device packaging.
The device parts could separate during medical procedures, potentially causing stroke or other complications if there's a delay or unplanned intervention.
Check the lot numbers on the device: 35264219, 35265391, 35265392, 35265399, 35265668, or 35265660.
No, but if you have the recalled lot numbers, contact your medical facility to ensure safety before any procedure.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1493-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1493-2023 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.
