Z-1533-2020 Class II Terminated
FDA device recall Z-1533-2020 was initiated by MEDTRONIC ATS MEDICAL, INC. on February 11, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated March 4, 2022). Affected quantity: 2 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 11, 2020
- Termination Date
- March 4, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 devices
Product Description
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
Reason for Recall
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.
Distribution Pattern
China
Code Information
UDI 00643169297913, Serial Numbers: 935603, 935732