GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
W L Gore & Associates, Inc. is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to catheter separation.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 7, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
W L Gore & Associates, Inc. initiated a voluntary recall of the GORE TAG Thoracic Branch Endoprosthesis Side Branch Component due to catheter separation. The recall is classified as Class II and remains ongoing.
Which Products Are Affected
The recall affects 467 devices distributed worldwide, including U.S. nationwide distribution in AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, and WI, plus the countries of United Arab Emirates, Australia, Austria, Canada, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Monaco, Malta, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovakia, Sweden, and Taiwan. Affected catalog numbers vary by region (United States/Canada, EMEA/Australia/New Zealand, Japan, China/Taiwan) and include TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A and corresponding regional variants. Specific serial numbers and UDI-DI codes are listed in FDA recall Z-2672-2026.
What You Should Do
No specific consumer action instructions are provided in the source data.
Why This Matters
The GORE TAG Thoracic Branch Endoprosthesis Side Branch Component is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta.
Source
https://www.fda.gov (Recall Number: Z-2672-2026, Event ID: 99140)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,556 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 7, 2026.
Frequently Asked Questions
Common questions about this FDA recall.