FDA Device recall Z-0136-2023
GORE CARDIOFORM ASD Occluder. cardiovascular implant
- FDA Device
- Class II
- ongoing
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of GORE CARDIOFORM ASD Occluder. cardiovascular implant by W L Gore And Associates, citing due to manufacturing records (Release Test Results) indicating "Failed".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0136-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-21 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | W L Gore And Associates |
| Distribution | US |
Product
GORE CARDIOFORM ASD Occluder. cardiovascular implant.
Reason
Due to manufacturing records (Release Test Results) indicating "Failed".
Identifiers
| code_info | Model Numbers: ASD37A UDI-DI Codes: 00733132636501 Serial Numbers: 24468090 24468092 24468093 24468096 24468097 2446809…Model Numbers: ASD37A UDI-DI Codes: 00733132636501 Serial Numbers: 24468090 24468092 24468093 24468096 24468097 24468098 24468099 24468103 24468104 24480314 24480315 24480316 24480318 24468102 24468094 24468100 24468101 24480317 24468091 24468095 Model Number: ASD44A UDI-DI Code: 00733132636518 Serial Numbers: 24281498 24281499 24281500 24281501 24281502 24281507 24281509 24281511 24281512 24429270 24429271 24429276 24429278 24429279 24480351 24480352 24480353 24545359 24550148 24550149 24578446 24578447 24281506 24429272 24429273 24429274 24429277 24545360 24545362 24550147 24550150 24550151 24578443 24578445 24281503 24281504 24281505 24281508 24281510 24429275 24480354 24480355 24545358 Model Number: ASD44E UDI-DI Code: 00733132636617 Serial Numbers: 24305083 24305081 24550693 24550694 24305079 24305080 24305082 24550695 24550696 24550697 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0136-2023%22
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