FDA-Device2021-12-01Class II

Cardioblate CryoFlex Surgical Ablation Console

Medtronic Perfusion Systems
Hazard

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

Sold states
Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Affected count
7 devices
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Cardioblate CryoFlex Surgical Ablation Console

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0273-2022

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