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MEDTRONIC ATS MEDICAL, INC. recalls Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Recalled April 1, 2020 · FDA recall Z-1533-2020 · MEDTRONIC ATS MEDICAL
Hazard
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. · FDA Class II
Units
2 devices
Sold at
China
Description
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.
Product
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Manufacturer(s)
MEDTRONIC ATS MEDICAL, INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →