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CryoLife, Inc. recalls On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, dama
Recalled September 13, 2017 · FDA recall Z-3108-2017 · CryoLife
Hazard
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients. · FDA Class II
Units
5 units
Sold at
US Distribution to the state of : Illinois
Description
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
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.
Manufacturer(s)
CryoLife, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →