MEDTRONIC ATS MEDICAL, INC.: Medical Device Recall in 2020 - (Recall #: Z-0496-2021)

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:

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.

Product Classification:

Class II

Date Initiated: October 12, 2020

Date Posted: December 2, 2020

Recall Number: Z-0496-2021

Event ID: 86666

Reason for Recall:

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

Status: Terminated

Product Quantity: 3 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated