Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager

Recall date

October 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0241-2020

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Sold / distributed

Worldwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager