Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic CryoConsole Recalled by Medtronic Inc. Cardiac Rhythm Disease Management Due to An issue with a USB memory component contained...

Date: September 1, 2015
Company: Medtronic Inc. Cardiac Rhythm Disease Management
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc. Cardiac Rhythm Disease Management directly.

Affected Products

Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

Quantity: 103 units

Why Was This Recalled?

An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Inc. Cardiac Rhythm Disease Management

Medtronic Inc. Cardiac Rhythm Disease Management has 23 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report