MEDTRONIC ATS MEDICAL, INC.: Medical Device Recall in 2020 - (Recall #: Z-0493-2021)

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 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: 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-0493-2021

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: 37 units

Code Information:

Model Number 60SF2, GTIN 00763000114619, Serial Numbers: 18920030, 18920031, 18920032, 18920033, 18920034, 18920035, 18920036, 18920037, 18920038, 18920039, 18920040, 18920041, 18920043, 18920045, 18920046, 18920047, 18920048, 18920049, 18920050, 18920051, 18920052, 18920053, 18920054, 18920055, 20420030, 20420031, 20420032, 20420033, 20420038, 20420039, 20420040, 20420041, 20420046, 20420047, 20420049, 20420050, 20420051

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated