FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-3108-2017
- Recalling firm
- CryoLife, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-02-12
- Posted
- not on file
- Terminated
- 2019-11-05
- 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
- Lot, serial or model codes
- Model No. ONXAAP; Serial No. 3260716, 3718302, 3190113, 3194122 and 3634902
- 510(k) numbers
- not on file
- PMA numbers
- ["P000037"]
- Product code
- NPT
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28