W L Gore recalls specific Thoracic Branch Endoprosthesis Side Branch Components (TSB081006A, TSB081206A, etc.) due to catheter separation risk. Affected units include certain model numbers sold in US, Canada, EMEA, Australia, New Zealand, Japan, China, and Taiwan.
Due to catheter separation
W L Gore is recalling specific Thoracic Branch Endoprosthesis Side Branch Components that may separate during use, potentially causing serious complications. This recall affects medical devices used in endovascular repair procedures.
The side branch components can separate during use, which may lead to blockages or other complications in the vascular system. This separation risk occurs during endovascular procedures where the device is used to repair aortic arch and descending thoracic aorta issues.
Healthcare professionals using these medical devices for endovascular repair procedures in the US, Canada, EMEA, Australia, New Zealand, Japan, China, and Taiwan. Patients who have received these components are at risk of complications.
Check for catalog numbers TSB081006A, TSB081206A, TSB081506A, TSB121506A, TSB121706A, or TSB122006A in the US and Canada; TSB081006E, TSB081206E, etc. in EMEA, Australia, New Zealand; TSB081006J, TSB081206J, etc. in Japan; TSB081006W, TSB081206W, etc. in China and Taiwan.
Identify the catalog number on your device (e.g., TSB081006A) to confirm if it's affected.
Reach out to W L Gore for specific instructions on how to report or replace the device.
The side branch components may separate during use, which could lead to blockages or complications in the vascular system.
The recall covers units sold in the US, Canada, EMEA countries, Australia, New Zealand, Japan, China, and Taiwan.
Check the catalog number on your device (e.g., TSB081006A, TSB081206A, etc.) against the listed affected numbers.
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-2672-2026 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-2672-2026 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.
