FDAOctober 3, 2019device

Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer — Recall Details · AllClear