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Medtronic Perfusion Systems Recall 88845

Description: Cardioblate CryoFlex Surgical Ablation Console

Medtronic Perfusion Systems Recall 88845 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0273-2022
Event ID88845
Event DescriptionCardioblate CryoFlex Surgical Ablation Console
Product TypeDevices
DistributionDistribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Quantity7 devices
Recall ReasonThere is potential for intermittent electrical connectivity between the console and probe.
Device Classification20211201
Device Code Info1) 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)
Center Classification Date20211119
Recall Initiation Date20210927
Recalling FirmMedtronic Perfusion Systems
Initial Notification Letter
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