MEDTRONIC ATS MEDICAL, INC.: Medical Device Recall in 2020 - (Recall #: Z-0495-2021)

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 60SF7, PROBE 60SF7 CRYOFLEX 7CM 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-0495-2021

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: 15 units

Code Information:

Model Number 60SF7, GTIN 00763000114633, Serial Numbers: 17720000, 17720001, 17720002, 17720011, 17720012, 17720013, 17720014, 17720015, 17720016, 17720017, 17720018, 17720019, 17720020, 17720021, 20620000

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated