CLASS II ONGOING Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
Gore Tag Conformable Thoracic Stent Graft with Active Control System recalled
W L Gore & Associates is recalling Gore Tag Conformable Thoracic Stent Graft with Active Control System, distributed nationwide in the US. The recall was initiated on 9 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0291-2021
- FDA event ID
- 86421
- Recalling firm
- W L Gore & Associates, Flagstaff, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2020
- FDA classified
- 23 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 9 Sep 2020 | Recall initiated by company | |
| 23 Oct 2020 | Classified by FDA | +44 days |
| 4 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Product as listed by the FDA
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Where it was distributed
U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
Questions about this recall
Why was it recalled?
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Which lots are affected?
CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan All Lot Numbers
Where was it sold?
U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from W L Gore & Associates
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled | W L Gore & Associates | Other | Nationwide |
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