FDAFDA · Food and drugs·Recall number Z-1533-2020
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Published April 1, 2020 · Recall initiated: February 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- MEDTRONIC ATS MEDICAL, INC.
- Distributor
- China
- Lot
- UDI 00643169297913, Serial Numbers: 935603, 935732
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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