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 affects specific lot numbers sold to hospitals and clinics.
The system could separate during medical procedures, especially if there's a delay or unplanned intervention. This separation might cause a stroke or other complications if the device is not properly secured.
Hospitals and clinics that purchased the recalled ANGIOGUARD RX/XP systems with specific lot numbers are affected. Medical staff using these systems during procedures are at risk if separation occurs.
Check the lot numbers listed: 35264218, 35264224, 35264206, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35265645, 35265653. The product is used in medical procedures and sold to hospitals.
Verify your device's lot number against the list: 35264218, 35264224, 35264206, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35265645, 35265653.
The ANGIOGUARD RX/XP system could separate during medical procedures, especially if there's a delay or unplanned intervention, potentially causing stroke or other complications.
Check the lot numbers listed: 35264218, 35264224, 35264206, 35264806, 35265342, 35265343, 35265382, 35265383, 35265646, 35265656, 35265658, 35265645, 35265653.
No, but you should check the lot numbers to see if your device is affected. If it is, you may need to take action to prevent separation during procedures.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1492-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1492-2023 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.
