Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1526-2014·Announced 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.

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. The source text describes a labeling issue regarding the cycling feature's impact on device longevity and recharge interval, without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving labeling or low-risk issues.

Plain-English summary

Medtronic Neuromodulation is recalling external neurostimulators, specifically models ENS (37021) and ENS (37022), along with associated software applications used during trialing for spinal cord stimulation patients. The recall involves 170,286 units in the US and 73,921 units outside the US, distributed nationwide including DC and Puerto Rico.

The recall is due to the device's cycling feature, which allows stimulation output to be toggled on and off based on programmed settings. Current labeling indicates that the use of this feature improves device longevity and recharge interval. The use of this feature is determined by the physician and set using the clinician programmer.

The first affected product was released to the market in April 2005. The source text does not specify specific actions for consumers or patients beyond the recall notice itself.

The recalled product

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.
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Neurostimulator
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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