Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.

Recall date

September 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2777-2015

FDA classification

Class II

Brand / firm

Medtronic Inc. Cardiac Rhythm Disease Management

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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