medical Class II Updated 2020-04-01

MEDTRONIC ATS MEDICAL, INC. recalls Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 2

Recalled Product

Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm


Hazard / Issue

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.

Issued by

FDA

Distribution: China
Lot/Code Info: UDI 00643169297913, Serial Numbers: 935603, 935732
View official government recall

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