Gore recalls certain AAA endoprosthesis models due to reports of leading end catheter component separations. Affected products include specific catalog numbers and sizes. Consumers should contact Gore for details.
Firm has received reports of leading end catheter component separations.
W. L. Gore & Associates recalls specific AAA endoprosthesis models because reports indicate leading end catheter components can separate. This could lead to complications during medical procedures if not addressed.
The recall is based on reports of leading end catheter components separating. This separation could cause complications during medical procedures, potentially leading to device failure or injury if not properly addressed.
Patients who have received the recalled endoprosthesis models are most at risk. Healthcare providers using these devices for surgeries may also need to take action.
Check for catalog numbers listed in the recall, such as PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB*. The products are available in specific sizes and configurations as detailed in the recall notice.
Reach out to W. L. Gore & Associates for specific information about your product and instructions on next steps.
The recall includes specific AAA endoprosthesis models with catalog numbers such as PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB*.
No immediate stop is required, but you should contact Gore to determine if your specific model is affected and follow their instructions.
Check the catalog numbers and sizes listed in the recall notice, which include specific configurations for trunk-ipsilateral leg, contralateral leg, iliac extender, and aortic extender components.
We’ve drafted a message you can send Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-0995-2020 — Gore Gore Hello, I own a Gore that is covered by recall Z-0995-2020 from 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.
