Recall Z-0273-2022 ยท OCL Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Medtronic Perfusion Systems
Cardioblate CryoFlex Surgical Ablation Console
| Date | Sep 27, 2021 |
| Status | Open, Classified |
| Reason | There is potential for intermittent electrical connectivity between the console and probe. |
| Root cause | Process control |
| Action | 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 Acti |
| Quantity | 7 devices |
| Distribution | Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123733 | CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM Medtronic, Inc., Apr 1, 2013 |