Medtronic Cardioblate CryoFlex Ablation Console Recalled for Electrical Connectivity Loss
Medtronic is recalling 7 Cardioblate CryoFlex Surgical Ablation Consoles due to potential intermittent electrical connectivity loss between the console and probe.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall of equipment used in critical cardiac surgical procedures with potential for loss of device functionality during operation. No incidents or injuries have been reported, but the device is used in high-risk surgical settings where functional failure poses potential risk of harm.
Plain-English summary
Medtronic Perfusion Systems is recalling 7 Cardioblate CryoFlex Surgical Ablation Consoles due to potential intermittent electrical connectivity between the console and probe.
The recalled devices are used in cardiac surgical ablation procedures. The potential issue involves intermittent electrical connectivity between the console and probe. Affected models are the 65CS1 and R65CS1, with specific serial numbers identified in the recall.
The devices were distributed in the United States in Illinois, Kansas, and Utah, as well as to Australia and South Korea.
The recalled product
- Product
- Cardioblate CryoFlex Surgical Ablation Console
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 7
Distribution
Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
Same hazard · electrical failure
See all →- High
- SevereJaguar Land Rover Recalls Vehicles for DC-DC Converter Defect
NHTSA · 2026-09-17
- High
- HighHalcore Recalls 2025-2026 Horton Ambulances Due to Touchscreen Failure
NHTSA · 2026-08-14
- HighMarion Recalls 2025 Pumper Fire Engines Due to Display Unit Failure
NHTSA · 2026-08-10
Similar recalls
- ModerateMedtronic Recalls CryoFlex Surgical Ablation Probes Due to Seal Defects
FDA (Devices) · 2020-12-02
- ModerateMedtronic Cardioblate CryoFlex Surgical Ablation Probe Recall for Seal Defects
FDA (Devices) · 2020-12-02
- ModerateMedtronic Cardioblate CryoFlex Surgical Ablation Probe Recalled for Seal Defects
FDA (Devices) · 2020-12-02
- HighMedtronic CryoConsole Recalled Due to USB Component Issue
FDA (Devices) · 2015-09-23
- SevereMedtronic Bio-Console 560 Blood Pumping Console Recalled for Electrical Failure
FDA (Devices) · 2021-04-07
- HighMedtronic Recalls Suction and Anticoagulation Assemblies Due to Connector Defects
FDA (Devices) · 2019-02-06