FDA recall Z-0273-2022

Medtronic Perfusion Systems · Class II · device

Product

Cardioblate CryoFlex Surgical Ablation Console

Reason for recall

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

Distribution

Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea

Key facts

Status
Ongoing
Initiation date
2021-09-27
Report date
2021-12-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brooklyn Park, MN, United States

Primary source

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