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.

Recall Insight

This FDA Devices action (record #Z-0496-2021) was formally reported on December 2, 2020, with the manufacturer initiating the action on October 12, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. MEDTRONIC ATS MEDICAL, INC. is listed as the recalling firm, operating out of Plymouth, MN. Federal records indicate 3 units units are affected.

The documented reason for this recall is: There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Belgium, Czech Republic, Germany, Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.