CryoLife, Inc. recalls On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damage…

Recall date

February 12, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3108-2017

FDA classification

Class II

Brand / firm

CryoLife, Inc.

Sold / distributed

US Distribution to the state of : Illinois

Why it was recalled

Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.