Recall Z-1533-2020— MEDTRONIC ATS MEDICAL, INC.

Name: FDA recall Z-1533-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-11

Class II · Terminated

Class II FDA medical device recall by MEDTRONIC ATS MEDICAL, INC., initiated 2020-02-11, terminated 2022-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm. Reason: 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..

Recalling firm: MEDTRONIC ATS MEDICAL, INC.
Classification: Class II
Status: Terminated
Initiated: 2020-02-11
Terminated: 2022-03-04
Firm location: Plymouth, MN, United States

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.