FDA (Devices) recall action 84026
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic is recalling 6,713 CareLink Encore Programmer units worldwide because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Medtronic is recalling CareLink SmartSync Device Manager units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.