medical Class II Updated 2021-12-01

Medtronic Perfusion Systems recalls Cardioblate CryoFlex Surgical Ablation Console

Recalled Product

Cardioblate CryoFlex Surgical Ablation Console

Hazard / Issue

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

Issued by

FDA

Affected States: IL, KS, UT
Lot/Code Info: 1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516)
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