Device 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.
Z-3108-2017
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 77728
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-3108-2017
Official wording
Reason: Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Code information: Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
Distribution pattern: US Distribution to the state of : Illinois
Derived failure modes
-
Unknown
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.