Company: Medtronic Inc. Cardiac Rhythm Disease Management
Date of Enforcement Report 9/23/2015
Class lI:
PRODUCT
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. Recall Number Z-2777-2015
REASON
Medtronic has identified an issue with a USB memory component contained within a subset of CryoConsoles. The issue can result in extended procedure time.
RECALLING FIRM/MANUFACTURER
Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN on 9/1/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
106 units
DISTRIBUTION
Worldwide..
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