The Recall Desk

FDA (Devices) recall action 66841

Medtronic Neuromodulation recalled 3 products on 2014-05-07

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.

Products
3
Announced
2014-05-07
Critical
0
Units
—

Why these products were recalled

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.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2014-05-07

    Medtronic External Neurostimulators Recalled for Cycling Feature Labeling Issue

    Medtronic is recalling external neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.

    Product
    Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and used during trialing for spinal cord stimulation (SCS) patients.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2014-05-07

    Medtronic Activa Neurostimulators Recalled for Cycling Feature Labeling

    Medtronic is recalling Activa neurostimulators because current labeling indicates the cycling feature improves device longevity and recharge interval.

    Product
    Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation for movement disorders.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2014-05-07

    Medtronic Neurostimulators Recalled for Cycling Feature Labeling Concerns

    Medtronic is recalling specific neurostimulators because current labeling indicates the cycling feature improves device longevity, a claim that may be inaccurate.

    Product
    Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (97702), RestoreULTRA (37712), RestoreULTRA SureScan MRI (97712), Itrel 4 (37703)…
    Category
    Distribution
    2 states