W L Gore recalls thoracic stent grafts with ACTIVE CONTROL System due to deployment failure risk. Affected models include TGM212110X* through TGMR404020X* with specific catalog numbers.
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
W L Gore is recalling thoracic stent grafts with the ACTIVE CONTROL System because a design flaw prevents proper deployment. This could lead to medical complications if the device fails to function correctly during surgery.
The secondary deployment fiber is attached to the secondary deployment handle, which prevents the device from being properly deployed through the deployment line access hatch. This could result in the device failing to function as intended during medical procedures.
Medical professionals using the recalled stent grafts during procedures are most at risk. Patients who have received these devices may also be affected depending on the procedure.
Check for catalog numbers starting with TGM212110X* through TGMR404020X* as listed in the recall notice. The *X* placeholder indicates specific regional variations.
Reach out to W L Gore directly to confirm if your device is affected and get guidance on next steps.
The recall is due to a design flaw where the secondary deployment fiber is attached to the secondary deployment handle, preventing proper deployment through the deployment line access hatch.
Affected models include catalog numbers TGM212110X* through TGMR404020X* with specific regional variations indicated by the *X* placeholder.
The recall does not specify a stop-use instruction, so you should contact W L Gore to determine if your device is affected.
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-0290-2021 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-0290-2021 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.
