FDA Device recall Z-2052-2020
Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the de…
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the de… by W L Gore And Associates, citing the incorrect label was placed on both the primary and secondary package.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2052-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-17 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | W L Gore And Associates |
| Distribution | n/a |
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
The incorrect label was placed on both the primary and secondary package.
Identifiers
| code_info | Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 2…Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2052-2020%22
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