Recall Z-3108-2017— CryoLife, Inc.
Class II · Terminated
Class II FDA medical device recall by CryoLife, Inc., initiated 2014-02-12, terminated 2019-11-05. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- CryoLife, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-12
- Terminated
- 2019-11-05
- Firm location
- Kennesaw, GA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.