W. L. Gore recalls EXCLUDER Ili: catheter component separations reported. Affected models include PLC, PLA, PLL, RLT23-35, HGB, and CEB sizes. No specific lots or serials. Contact for remedy.
Firm has received reports of leading end catheter component separations.
W. L. Gore is recalling its EXCLUDER Iliac Branch Endoprosthesis (IBE) implants due to reports of end catheter components separating. This could lead to complications during medical procedures if the device fails.
The device has reported separations in the end catheter component, which could cause complications during medical procedures if the device fails. This is a mechanical failure risk during implantation or use.
Patients receiving this specific type of vascular implant are affected. Medical professionals using the device during procedures are at highest risk.
Check if your implant has catalog numbers PLC, PLA, PLL, RLT23, RLT26, RLT28, RLT31, RLT35, HGB, or CEB. The product is not tied to specific lot or serial numbers.
Reach out to W. L. Gore for specific instructions on next steps after identifying the affected product.
No, the recall applies to all products with the listed catalog numbers, not specific lots or serial numbers.
Check if your implant has catalog numbers PLC, PLA, PLL, RLT23, RLT26, RLT28, RLT31, RLT35, HGB, or CEB.
Contact W. L. Gore for specific instructions on next steps after identifying the affected product.
We’ve drafted a message you can send W. L. Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-0996-2020 — W. L. Gore W. L. Gore Hello, I own a W. L. Gore that is covered by recall Z-0996-2020 from W. L. Gore. 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.
