The Recall Desk

FDA (Devices) recall action 66473

Medtronic Neuromodulation recalled 2 products on 2013-11-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-11-06
Critical
0
Units
102,457

Why these products were recalled

Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2013-11-06

    Medtronic Activa Deep Brain Stimulators Recalled for Potential Overstimulation

    Medtronic is recalling Activa PC and RC deep brain stimulators due to a potential for overstimulation or stimulation in the wrong area during device recovery.

    Product
    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the inte
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-11-06

    Medtronic RestoreUltra and RestoreSensor Neurostimulators Recalled for Stimulation Issues

    Medtronic is recalling RestoreUltra and RestoreSensor neurostimulators because they may deliver over-stimulation or stimulation to the wrong area under specific conditions.

    Product
    Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of ch
    Category
    Distribution
    1 state