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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Recalled November 6, 2019 · FDA recall Z-0241-2020 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
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. · FDA Class II
Units
874 units
Sold at
Worldwide Distribution
Description
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.
Product
Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →