Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Open Pivot Aortic Valve Graft Recalled by MEDTRONIC ATS MEDICAL, INC. Due to Medtronic received a complaint from China that the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MEDTRONIC ATS MEDICAL, INC. directly.
Affected Products
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Quantity: 2 devices
Why Was This 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.
Where Was This Sold?
China
About MEDTRONIC ATS MEDICAL, INC.
MEDTRONIC ATS MEDICAL, INC. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report