Home / Recalls / MEDTRONIC ATS MEDICAL, INC. / Z-0496-2021

Z-0496-2021 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
December 2, 2020
Initiation Date
October 12, 2020
Termination Date
August 16, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3 units

Product Description

Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.

Reason for Recall

There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices

Distribution Pattern

Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.

Code Information

Model Number 60CM1, GTIN 00763000114640, Serial Numbers: 18920000, 18920001, 18920002

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-1533-2020 Class II — Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm (February 11, 2020)