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 certain ANGIOGUARD RX/XP Emboli Capture Guidewire Systems because they might separate during medical procedures, potentially causing stroke or other complications. This recall affects specific lot numbers used in surgeries.
The guidewire system could separate during medical procedures, especially if there's a delay or unplanned intervention. This separation might cause stroke or other complications if the system is not properly secured.
Medical professionals using the recalled guidewire systems during procedures are most at risk. Patients undergoing surgery with these systems could face complications if separation occurs.
Check the lot numbers listed: 35264217, 35264226, 35265330, 35265344, 35265381, 35265641, 35265652, 35265655, 35264205, 35264210, 35264214, 35265340, 35265341, 35265394, 35265643. The product is used in medical procedures and is not sold to the general public.
Verify your device's lot number against the list: 35264217, 35264226, 35265330, 35265344, 35265381, 35265641, 35265652, 35265655, 35264205, 35264210, 35264214, 35265340, 35265341, 35265394, 35265643.
The product is safe for use in most cases, but there is a risk of separation during procedures, which could lead to complications like stroke. Always follow the recall instructions.
Check your lot number against the list provided. If it matches, contact Cordis for further instructions.
The recall does not specify a replacement process. Contact Cordis directly for details on how to proceed.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1491-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1491-2023 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.
