FDA Device recall Z-3108-2017
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use
- FDA Device
- Class II
- terminated
- Published 2017-09-13
On 2017-09-13 the FDA classified a Class II recall of On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use by Cryolife, citing mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3108-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-12 |
| Published | 2017-09-13 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cryolife |
| Distribution | IL |
Product
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
Reason
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Identifiers
| code_info | Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Cryolife
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FDA Device · Class II · 2021-12-22 · Cryolife - CryoPatch SG Pulmonary Human Cardiac Patch
FDA Device · Class II · 2020-12-30 · Cryolife - CryoValve SG Pulmonary Human Heart Valve
FDA Device · Class II · 2020-12-30 · Cryolife - CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Device · Class II · 2019-05-01 · Cryolife - On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseas…
FDA Device · Class II · 2019-04-03 · Cryolife
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3108-2017%22
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