The Recall Desk
HighFDA (Devices)·Z-0273-2022·Announced 2021-12-01

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.

What this means for you

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
Category
Medical Device — Cardiac Surgery Equipment
Hazard
Affected units
7

Distribution

Distributed in 3 states:

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