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Recall Observatory FDA recall evidence

Device product

Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm

Z-1533-2020

February 11, 2020

Class II

Product summary

Firm
MEDTRONIC ATS MEDICAL, INC.
Event
Event 85092
Status
Terminated
Classification
Class II
Quantity
2 devices
Official record key
device-enforcement:Z-1533-2020

Official wording

Reason: 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.

Code information: UDI 00643169297913, Serial Numbers: 935603, 935732

Distribution pattern: China

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.