FDA Device recall Z-0048-2018
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of…
- FDA Device
- Class II
- terminated
- Published 2017-11-01
On 2017-11-01 the FDA classified a Class II recall of GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesions of… by W L Gore And Associates, citing incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0048-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-25 |
| Published | 2017-11-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | W L Gore And Associates |
| Distribution | n/a |
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
Incomplete and/or partial deployment of the CTAG Device during the endovascular procedure.
Identifiers
| code_info | Serial Numbers: TGE212110 TGE212110 TGE212110K TGU212110 TGU212110H TGU212110B TGU212110J TGE262610 TGE262610 TGE26261…Serial Numbers: TGE212110 TGE212110 TGE212110K TGU212110 TGU212110H TGU212110B TGU212110J TGE262610 TGE262610 TGE262610K TGU262610 TGU262610H TGU262610B TGU262610J TGE282810 TGE282810 TGE282810K TGU282810 TGU282810H TGU282810B TGU282810J TGE282815 TGE282815 TGE282815K TGU282815 TGU282815H TGU282815B TGU282815J TGE313110 TGE313110 TGE313110K TGU313110 TGU313110H TGU313110B TGU313110J TGE313115 TGE313115 TGE313115K TGU313115 TGU313115H TGU313115B TGU313115J TGE343410 TGE343410 TGE343410K TGU343410 TGU343410H TGU343410B TGU343410J TGE343415 TGE343415 TGE343415K TGU343415 TGU343415H TGU343415B TGU343415J TGE343420 TGE343420 TGE343420K TGU343420 TGU343420H TGU343420B TGU343420J TGE373710 TGE373710 TGE373710K TGU373710 TGU373710H TGU373710B TGU373710J TGE373715 TGE373715 TGE373715K TGU373715 TGU373715H TGU373715B TGU373715J TGE373720 TGE373720 TGE373720K TGU373720 TGU373720H TGU373720B TGU373720J TGE404010 TGE404010 TGE404010K TGU404010 TGU404010H TGU404010B TGU404010J TGE404015 TGE404015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0048-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.