Conformable Thoracic Stent Graft — Class II medical device recall Z-2052-2020
Terminated recall by W L Gore & Associates, Inc., reported 2020-05-27. The incorrect label was placed on both the primary and secondary package.
| Recall number | Z-2052-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | W L Gore & Associates, Inc., Flagstaff, AZ, United States |
| Recall initiated | 2019-12-17 |
| Classified | 2020-05-20 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-04-28 |
| Countries outside the US | JP |
| Quantity | 15 stents |
| Reason classes | labeling |
| Serial numbers | 21225065, 21225066, 21225067, 21225068, 21225069, 21225070, 21225071, 21225072, 21225073, 21225074, 21225075, 21225076, 21225077, 21225078, 21225079, 21225080, 21225081, 21225082, 21225083, 21225084 |
Product
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
Reason for recall
The incorrect label was placed on both the primary and secondary package.
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-2052-2020. 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.