Cardioblate CryoFlex Surgical Ablation Console
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- September 27, 2021
- Recall Number
- Z-0273-2022
- Quantity
- 7 devices
- Firm Location
- Brooklyn Park, MN
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
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)
Root Cause
Process control
Action Taken
In the United States (US), beginning 27-SEP-2021 Medtronic initiated communications of an Urgent Medical Device Correction letter via 2-day UPS delivery to consignees who have received affected product according to Medtronic records. Outside of the United States (OUS), beginning 27-SEP-2021, a written Urgent Medical Device Correction letter is being delivered via regionally approved methods to consignees who have received affected product according to Medtronic records. Consignees are asked to review the Medtronic Urgent Medical Device Correction notification and follow the Recommended Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.