Recall Z-3108-2017 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
CryoLife, Inc.
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.
| Date | Feb 12, 2014 |
| Status | Terminated |
| Reason | Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. |
| Root cause | Other |
| Action | On February 12, 2014, it was discovered that five devices were processed under the wrong RGA number This is a retrospective reporting. Three units were collected and returned to the firm, while two were implanted. For further questions, please call ( 770) 419-3355. |
| Quantity | 5 units |
| Distribution | US Distribution to the state of : Illinois |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.