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 and requires immediate attention from healthcare providers using the product.
The system could separate during medical procedures if there's an intra-procedural delay, unplanned surgical intervention, or stroke. This separation might cause the capture sheath to become dislodged, leading to complications like stroke.
Healthcare providers using the recalled ANGIOGUARD RX/XP Emboli Capture Guidewire Systems are most at risk, particularly during procedures involving potential delays or unplanned interventions.
Check the lot numbers on the product: 35264208, 35264212, 35265329, 35265654, 35265649, or 35265667. The product is sold under the ANGIOGUARD RX/XP Emboli Capture Guidewire System name.
Verify the lot numbers on the product: 35264208, 35264212, 35265329, 35265654, 35265649, or 35265667.
The system could separate during medical procedures, potentially causing stroke or other complications if there's an intra-procedural delay, unplanned surgical intervention, or stroke.
Check the lot numbers: 35264208, 35264212, 35265329, 35265654, 35265649, or 35265667.
No, but healthcare providers should be cautious during procedures and avoid using the product if there's a risk of separation.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1484-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1484-2023 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.
