MEDTRONIC ATS MEDICAL, INC.: Medical Device Recall in 2020 - (Recall #: Z-0494-2021)

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 60SF3, PROBE 60SF3 CRYOFLEX 10-S 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-0494-2021

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: 57 units

Code Information:

Model Number 60SF3, GTIN 00763000114626 Serial Numbers: 17420000, 17420001, 17420002, 17420003, 17420004, 17420005, 17420006, 17420007, 17420008, 17420009, 17420010, 17420013, 17420014, 17420015, 17420016, 17420017, 17420018, 17420019, 17420020, 17420022, 17420023, 17420024, 17420025, 17420026, 17420027, 17420028, 17420029, 18420000, 18420001, 18420002, 18420003, 18420004, 18420015, 18420016, 18420021, 18420022, 18420023, 18420024, 18420025, 18420026, 18420027, 19820016, 19820017, 19820018, 19820019, 19820020, 19820021, 19820022, 19820023, 19820024, 21020005, 22320038, 22320040, 22320041, 22320042, 22320043, 22320044

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated