W L Gore recalls conformable thoracic stent grafts with Active Control System due to delivery catheter connection preventing removal. Affected units include specific catalog numbers and all lot numbers. Consumers should contact for details.
When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
W L Gore is recalling conformable thoracic stent grafts with Active Control System because the delivery catheter can become stuck during removal. This could prevent proper medical treatment if the device needs to be taken out.
When trying to remove the delivery catheter, the stent graft can become connected, preventing the catheter from being withdrawn. This could block the device from being safely removed, potentially causing complications during medical treatment.
Patients who have received this specific stent graft device are most at risk. The recall affects medical devices used in thoracic procedures.
Check for catalog numbers starting with TGM or TGMR followed by numbers and an X (e.g., TGM212110X*). All lot numbers are affected. The product is used in thoracic procedures.
Reach out to W L Gore for specific instructions on how to handle the recalled device.
The delivery catheter can become stuck to the stent graft, preventing removal during medical procedures.
Catalog numbers starting with TGM or TGMR followed by numbers and an X (e.g., TGM212110X*).
No immediate stop is required, but affected patients should contact W L Gore for guidance.
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-0291-2021 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0291-2021 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.
