On-X Prosthetic Heart Valve with Gelweave Valsalva Graft — Class II medical device recall Z-3108-2017
Terminated recall by CryoLife, Inc., reported 2017-09-13, distributed in IL. Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
| Recall number | Z-3108-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2014-02-12 |
| Classified | 2017-09-06 |
| Reported by FDA | 2017-09-13 |
| Terminated | 2019-11-05 |
| Distributed | IL |
| Quantity | 5 units |
| Serial numbers | 3190113, 3194122, 3260716, 3634902, 3718302 |
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 for recall
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
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-3108-2017. 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.