Medtronic Perfusion Systems Recall 88845
Description: Cardioblate CryoFlex Surgical Ablation Console
Medtronic Perfusion Systems Recall 88845 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0273-2022 |
| Event ID | 88845 |
| Event Description | Cardioblate CryoFlex Surgical Ablation Console |
| Product Type | Devices |
| Distribution | Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea |
| Quantity | 7 devices |
| Recall Reason | There is potential for intermittent electrical connectivity between the console and probe. |
| Device Classification | 20211201 |
| Device 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) |
| Center Classification Date | 20211119 |
| Recall Initiation Date | 20210927 |
| Recalling Firm | Medtronic Perfusion Systems |
| Initial Notification | Letter |
| Similar To |