MEDTRONIC ATS MEDICAL, INC. recalls Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
- Recall date
- February 11, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1533-2020
- FDA classification
- Class II
- Brand / firm
- MEDTRONIC ATS MEDICAL, INC.
- Sold / distributed
- China
Why it was recalled
Medtronic received a complaint from China that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
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