Agency classClass IIOur severity:High FDA (Devices)·Z-2259-2014·Announced 2014-08-27

Medtronic Recalls Six Activa PC Implantable Neurostimulators

Medtronic is recalling six Activa PC implantable neurostimulators due to a potential manufacturing defect in an electrical component.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk implanted medical device with a potential manufacturing defect, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic Neuromodulation is recalling six units of the Activa PC (model 37601) Implantable Neurostimulator. The recall is due to the potential for a damaged electrical component during the manufacturing process.

The Activa PC is a dual-channel neurostimulator that delivers controlled electrical pulses to targeted areas of the brain. It is typically implanted subcutaneously near the clavicle and connected to leads implanted in the brain. The device contains a non-rechargeable battery and microelectronic circuitry.

The affected units were distributed in Massachusetts, North Carolina, Ohio, and Texas. The specific serial numbers for the recalled devices are NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, and NKM724843H. Patients with these specific serial numbers should contact their healthcare provider or Medtronic for instructions on next steps.

The recalled product

Product: Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic…
Manufacturer: Medtronic Neuromodulation
Category: Medical Device — Implantable Neurostimulator
Hazard: electrical-defect
Affected units: 6

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 (6)

Serial numbers: NKM724776H
NKM724782H
NKM724785H
NKM724790H
NKM724802H
NKM724843H.

Distribution

Distributed in 4 states:

Same manufacturer · Medtronic Neuromodulation

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