Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1524-2014·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a labeling concern regarding device longevity claims without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Medtronic Neuromodulation is recalling specific neurostimulator models, including the Restore, RestoreADVANCED, RestoreSENSOR, RestoreULTRA, Itrel 4, RestorePrime, and PrimeAdvanced series. These devices are used for pain and deep brain stimulation therapy. The recall involves 170,286 units in the United States and 73,921 units outside the United States.

The recall is initiated because the current labeling indicates that using the cycling feature improves device longevity and recharge interval. The cycling feature allows stimulation output to be toggled on and off based on programmed settings, a function determined by the physician and set using a clinician programmer. The source text does not specify reported injuries, illnesses, or deaths associated with this labeling issue.

Patients using these devices should contact their physician or Medtronic for further instructions regarding the recall and any necessary device adjustments or replacements.

The recalled product

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)…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Neurostimulators
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

The first released affected product was released to the market in April
2005.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Medtronic Neuromodulation

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