Home / Recalls / MEDTRONIC ATS MEDICAL, INC. / Z-1533-2020

Z-1533-2020 Class II Terminated

Recalled by MEDTRONIC ATS MEDICAL, INC. — Plymouth, MN

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

Other recalls by MEDTRONIC ATS MEDICAL, INC.

  • Z-0494-2021 Class II — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 C (October 12, 2020)
  • Z-0495-2021 Class II — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 C (October 12, 2020)
  • Z-0493-2021 Class II — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 C (October 12, 2020)
  • Z-0496-2021 Class II — Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 C (October 12, 2020)