W L Gore recalls specific Conformable Thoracic Stent Graft models with incorrect labeling that could lead to improper use. Affected units have serial numbers 21225065-21225084.
The incorrect label was placed on both the primary and secondary package.
W L Gore is recalling a specific set of Conformable Thoracic Stent Grafts due to incorrect labeling on both the primary and secondary packaging. This could lead to improper use if the device is not correctly identified before medical procedures.
The device has incorrect labeling on both the primary and secondary packaging. This could lead to improper identification during medical procedures, potentially causing incorrect use in endovascular repair of the descending thoracic aorta.
Medical professionals who use this device for endovascular repair of the thoracic aorta are most at risk. Patients receiving this procedure may be affected if the wrong device is used.
Check for serial numbers 21225065 through 21225084 on the device packaging. The product is a Conformable Thoracic Stent Graft intended for endovascular repair of the descending thoracic aorta.
Check that the primary and secondary packaging have correct labels for the Conformable Thoracic Stent Graft.
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Serial numbers 21225065 through 21225084.
The recall record does not specify a remedy.
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-2052-2020 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-2052-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
