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 ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with certain lot numbers because they might separate during medical procedures, potentially causing complications like stroke. This recall affects patients undergoing specific surgeries where the device is used.
The device could separate during medical procedures, especially if there's a delay or unplanned intervention. This separation might cause complications like stroke if the device is not properly secured.
Patients using this device during medical procedures are affected. Those undergoing surgeries where the device is used are at the highest risk.
Check the lot numbers: 35265658, 35264211, 35264225, 35265647. The product is used in medical procedures and has a specific UDI/DI code: 20705032056738.
Look for lot numbers 35265658, 35264211, 35264225, or 35265647 on the product packaging.
Inform your doctor or healthcare provider about the recall if you have the affected device.
The device might separate during medical procedures, especially if there's a delay or unplanned intervention, which could lead to complications like stroke.
Check the lot numbers: 35265658, 35264211, 35264225, or 35265647. The product has a UDI/DI code of 20705032056738.
Contact your healthcare provider to discuss next steps, as the recall does not include a specific remedy like replacement or return.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1494-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1494-2023 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.