Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with potential separation during procedures, risking stroke or complications. Affected units have 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 that could separate during medical procedures, potentially causing stroke or other complications. This risk occurs if there's a delay in treatment or unplanned surgery.
The device could separate during medical procedures if there's a delay in treatment or unplanned surgical intervention. This separation might lead to stroke or other complications if the replacement device isn't ready.
Healthcare professionals using the ANGIOGUARD RX/XP system for procedures are most at risk. Patients undergoing these procedures may be affected if the device separates during treatment.
Check for the reference code 801814RE and lot number 35267611 on the device packaging. The device was sold with UDI/DI 20705032056929.
Look for reference code 801814RE and lot number 35267611 on the device packaging.
The recall states the device could separate during procedures like delays or unplanned interventions, but it is not inherently dangerous if used correctly.
The recall record does not specify a remedy, so contact Cordis directly for guidance.
The recall indicates a potential risk during procedures, so healthcare professionals should check with Cordis before continuing use.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1496-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1496-2023 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.
