Home / Recalls / Medical Devices
Medtronic Inc. Cardiac Rhythm Disease Management recalls Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Recalled September 23, 2015 · FDA recall Z-2777-2015 · Medtronic Inc. Cardiac Rhythm Disease Management
Hazard
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time. · FDA Class II
Units
103 units
Sold at
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.
Description
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
Product
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Manufacturer(s)
Medtronic Inc. Cardiac Rhythm Disease Management
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →