Medtronic Open Pivot Aortic Valve Graft recall
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Why was Medtronic Open Pivot Aortic Valve Graft 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 00643169297913, Serial Numbers: 935603, 935732
- Product
- Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
- Recalling firm
- MEDTRONIC ATS MEDICAL, INC.
- Quantity
- 2 devices
- Distribution
- China
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)