Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1525-2014·Announced 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.

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 without reporting specific injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

Medtronic Neuromodulation is recalling specific models of the Activa multi-program rechargeable neurostimulator, including the Activa RC, PC, SC, and PC+S models. These devices are used for deep brain stimulation for movement disorders and pain therapy.

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

The recall covers 170,286 units in the US and 73,921 units outside the US. The first affected product was released to the market in April 2005. Distribution was nationwide, including all states, DC, and Puerto Rico.

The recalled product

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.
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

See all →

Moderate
Medtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
Moderate
Medtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
High
Medtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
Moderate
Neurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
High
Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31

Same hazard · mis labeling