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 affects specific lot numbers and reference codes.
The system could separate during medical procedures, especially if there's a delay or unplanned intervention. This separation might cause stroke or other complications while waiting for a replacement device.
Medical professionals using the ANGIO:RX/XP Emboli Capture Guidewire System during procedures are most at risk. Patients undergoing the procedure with affected devices may face complications.
Check for the reference code 501814RM and lot numbers starting with 35265644 on the device packaging. The unique device identifier (UDI/DI) 20705032054796 is also associated with this recall.
Verify the reference code 501814RM and lot numbers starting with 35265644 on the device packaging.
The reference code is 501814RM and lot numbers start with 35265644.
Yes, separation during procedures could lead to stroke or complications if not addressed.
Check the reference code and lot numbers on the device packaging to confirm if it's affected.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1495-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1495-2023 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.
