FDA-Device2020-04-01Class II
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
MEDTRONIC ATS MEDICAL, INC.
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.
Sold states
China
Affected count
2 devices
Manufactured in
3800 Annapolis Ln N, N/A, Plymouth, MN, United States
Products
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1533-2020Don't want to check this manually?
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