Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with potential separation during procedures, risking stroke or complications. Affected units include specific model and lot numbers.
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 model numbers and lot ranges.
The device may separate during medical procedures, especially if there's a delay in treatment, unplanned surgery, or if a replacement device isn't ready. This separation could cause stroke or other complications.
Healthcare professionals using the ANGIOGUARD RX/XP system during procedures are most at risk. Patients undergoing the procedures with the recalled device could face complications if separation occurs.
Check for the model number REF 603014MC and lot numbers starting with 35265492 on the device. The UDI/DI code 20705032056790 is also associated with the recalled units.
Look for the model number REF 603014MC and lot numbers starting with 35265492 on the device.
The specific model number is REF 603014MC.
Lot numbers starting with 35265492 are affected.
Yes, separation during procedures could lead to stroke or other complications.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1488-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1488-2023 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.
