GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System — Class II medical device recall Z-0291-2021
Ongoing recall by W L Gore & Associates, Inc., reported 2020-11-04, distributed nationwide. When the delivery catheter was attempted to be removed, there was an observed connection between the stent gra
| Recall number | Z-0291-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2020-09-09 |
| Classified | 2020-10-23 |
| Reported by FDA | 2020-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CZ, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, LB, LU, NL, NO, NZ, PL, PT, SA, SE, SI, ZA |
| Quantity | 19,013 units |
Product
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0291-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.