Reported Apr 1, 2020 · Terminated
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Medtronic Ats Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDTRONIC ATS MEDICAL, INC. · 3800 Annapolis Ln N · Plymouth, MN · 55447-5439
Is this the product you have?
Medtronic Open Pivot Aortic Valve GraftREF 502AG25SIZE 25 mm
- Lot codes and dates
- UDI 00643169297913
- Serial Numbers
935603935732
- Amount recalled
- 2 devices
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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