Recall Z-0241-2020— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2019-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager. Reason: There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-10-03
- Firm location
- Mounds View, MN, United States
Product description
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Reason for recall
There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. This issue does not impact device functionality.
Data sourced from openFDA. This site is unofficial and independent of the FDA.