MEDTRONIC ATS MEDICAL, INC.: Medical Device Recall in 2020 - (Recall #: Z-1533-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 11, 2020

Date Posted: April 1, 2020

Recall Number: Z-1533-2020

Event ID: 85092

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.

Status: Terminated

Product Quantity: 2 devices

Code Information:

UDI 00643169297913, Serial Numbers: 935603, 935732

Distribution Pattern:

China

Voluntary or Mandated:

Voluntary: Firm initiated