Cordis recalls ANGIOGUARD RX/XP Emboli Capture Guidewire Systems with specific lot numbers due to potential separation during medical procedures, which could lead to stroke or other complications.
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 ANGIOGUARD RX/XP Emboli Capture Guidewire Systems because they might separate during medical procedures, potentially causing stroke or other complications. This recall affects specific lot numbers and requires immediate attention from healthcare providers using the device.
The device could separate during medical procedures, especially if there's a delay in treatment or unplanned surgical intervention. This separation might cause a stroke or other complications if the device is not properly secured.
Healthcare providers who use the ANGIOGUARD RX/XP Emboli Capture Guidewire System during medical procedures are most at risk if the device separates during surgery or a procedure delay. This recall applies to specific lot numbers manufactured between certain dates.
Check the lot numbers on the device: 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, 35265659. The product is sold under the brand name Cordis and model ANGIOGUARD RX/XP Emboli Capture Guidewire System.
Verify the lot numbers on your device: 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, 35265659.
The device could separate during medical procedures, especially if there's a delay in treatment or unplanned surgical intervention, which might cause a stroke or other complications.
Lot numbers 35263328, 35264207, 35264213, 35264216, 35265393, 35265648, 35265659 are affected.
Healthcare providers should check the lot numbers on their device. If it matches the affected numbers, they should stop using it and contact Cordis for further instructions.
We’ve drafted a message you can send Cordis to request your refund or repair — edit it as you like.
Subject: Recall Z-1485-2023 — Cordis Cordis Hello, I own a Cordis that is covered by recall Z-1485-2023 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.
