Device product

Cardioblate CryoFlex Surgical Ablation Console

Z-0273-2022

September 27, 2021

Class II

Product summary

Firm: Medtronic Perfusion Systems
Event: Event 88845
Status: Ongoing
Classification: Class II
Quantity: 7 devices
Official record key: device-enforcement:Z-0273-2022

Official wording

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

Code information: 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)

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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