GORE TAG — Class II medical device recall Z-0048-2018
Terminated recall by W L Gore & Associates, Inc., reported 2017-11-01. Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
| Recall number | Z-0048-2018 |
|---|---|
| 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 | 2017-09-25 |
| Classified | 2017-10-25 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2019-08-27 |
| Quantity | 12,197 units |
| Serial numbers | TGE212110, TGE212110K, TGE262110, TGE262110K, TGE262610, TGE262610K, TGE282810, TGE282810K, TGE282815, TGE282815K, TGE312610, TGE312610K, TGE313110, TGE313110K, TGE313115, TGE313115K, TGE343410, TGE343410K, TGE343415, TGE343415K, TGE343420, TGE343420K, TGE373710, TGE373710K, TGE373715 and 101 more |
Product
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of the descending thoracic aorta.
Reason for recall
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
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-0048-2018. 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.