Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with potential separation during medical 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 ANG:RX/XP Emboli Capture Guidewire Systems due to a risk of separation during medical procedures, which could lead to stroke or complications if not addressed. This affects specific lot numbers and reference codes.
The system may separate during medical procedures, especially if there's a delay, unplanned surgery, or if a replacement device isn't ready. This separation could cause stroke or other complications.
Medical professionals using the ANGIOGUARD RX/XP Emboli Capture Guidewire System during procedures are most at risk. Patients undergoing the procedure with the affected device could face complications.
Check for the reference code 501814REC and lot number 35264223 on the device. The product was sold with UDI/DI 20705032054789.
Look for the reference code 501814REC and lot number 35264223 on the device.
The reference code is 501814REC and lot number 35264223.
Separation could lead to stroke or complications if the device is not properly replaced during medical procedures.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1489-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1489-2023 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.
