Cardioblate CryoFlex Surgical Ablation Console
FDA Recall Z-0273-2022 · Posted None
Recalling FirmMedtronic Perfusion Systems
Recall StatusOpen, Classified
Product CodeOCL
Date Initiated2021-09-27
Product Quantity7 devices
Reason for Recall
There is potential for intermittent electrical connectivity between the console and probe.
Firm 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 Actions, including quarantining affected Cardioblate CryoFlex Surgical Ablation Consoles in their inventory for servicing.
Root Cause
Process control
Distribution Pattern
Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.