Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with specific lot numbers due to potential separation during medical procedures, which could lead to complications like stroke.
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 certain ANGIOGU: RX/XP Emboli Capture Guidewire Systems because they might separate during medical procedures, potentially causing complications like stroke. This affects patients undergoing specific surgeries or procedures using the recalled models.
The system could separate during medical procedures if there's a delay, unplanned surgery, or other interventions. This separation might lead to complications like stroke if a replacement device isn't immediately available.
Patients using the recalled ANGIOGUARD RX/XP systems during medical procedures are most at risk. The recall applies to specific lot numbers and model references sold in the U.S.
Check the lot numbers: 35262517, 35263334, 35264204, 35264222, or 35265345. The product includes the UDI/DI code 20705032053508 and is labeled as ANGIOGUARD RX/XP Emboli Capture Guidewire System.
Look for lot numbers 35262517, 35263334, 35264204, 35264222, or 35265345 on the device packaging or label.
The recalled device is the ANGIOGUARD RX/XP Emboli Capture Guidewire System with lot numbers 35262517, 35263334, 35264204, 35264222, or 35265345.
There is a potential for the device to separate during medical procedures, which could lead to complications like stroke if a replacement device isn't immediately available.
The recall does not require immediate discontinuation; however, patients using the device during procedures should ensure a replacement is prepared if there's a delay or unplanned intervention.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1483-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1483-2023 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.
