Recall Z-2777-2015— Medtronic Inc. Cardiac Rhythm Disease Management
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2015-09-01, terminated 2016-04-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.. Reason: An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time..
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-09-01
- Terminated
- 2016-04-08
- Firm location
- Saint Paul, MN, United States
Product description
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
Reason for recall
An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.
Data sourced from openFDA. This site is unofficial and independent of the FDA.