# FDA recall Z-0495-2021

> **MEDTRONIC ATS MEDICAL, INC.** · Class II · device recall initiated 2020-10-12.

## Product

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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0495-2021
- **Recalling firm:** MEDTRONIC ATS MEDICAL, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-12
- **Report date:** 2020-12-02
- **Termination date:** 2024-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0495-2021

## Citation

> AI Analytics. FDA recall Z-0495-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0495-2021. Source: US FDA. Licensed CC0.

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