Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with potential separation during procedures, risking stroke or complications. Affected units include specific lot numbers and reference 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 recall affects specific lot numbers and reference codes used in certain surgical settings.
The system could separate during procedures if there's a delay, unplanned surgery, or other interruptions. This separation might cause 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 surgeries with this device may be affected if the system separates during treatment.
Check for the reference code 401814RM and lot numbers 35265339 or 352:65670 on the device packaging. The system was sold with UDI/DI 20705032053492.
Look for the reference code 401814RM and lot numbers 35265339 or 35265670 on the device packaging.
The system could separate during procedures if there's a delay, unplanned surgery, or other interruptions, potentially causing stroke or complications while waiting for a replacement device.
Check for the reference code 401814RM and lot numbers 35265339 or 35265670 on the device packaging. The system was sold with UDI/DI 20705032053492.
The recall record does not specify a remedy, so contact Cordis directly for guidance.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1490-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1490-2023 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.
