PlainRecalls
FDA Devices Moderate Class II Ongoing

Cardioblate CryoFlex Surgical Ablation Console

Reported: December 1, 2021 Initiated: September 27, 2021 #Z-0273-2022

Product Description

Cardioblate CryoFlex Surgical Ablation Console

Reason for Recall

There is potential for intermittent electrical connectivity between the console and probe.

Details

Units Affected
7 devices
Distribution
Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Location
Brooklyn Park, MN

Frequently Asked Questions

What product was recalled?
Cardioblate CryoFlex Surgical Ablation Console. Recalled by Medtronic Perfusion Systems. Units affected: 7 devices.
Why was this product recalled?
There is potential for intermittent electrical connectivity between the console and probe.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 1, 2021. Severity: Moderate. Recall number: Z-0273-2022.