FDA (Devices) recall action 66841
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.
Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling feature that, when enabled, allows stimulation output to be toggled on and off based on the programmed settings. The use of this feature is determined by the physician and set using the clinician programmer. Current labeling indicates the use of cycling improves device longevity and recharge interval
The agency’s own wording, quoted from the enforcement report.
Medtronic is recalling Activa neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.
Medtronic is recalling specific neurostimulators because current labeling indicates the cycling feature improves device longevity, a claim that may be inaccurate.
Medtronic is recalling external neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.