Medtronic Neuromodulation: Medical Device Recall in 2014 - (Recall #: Z-2259-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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 circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.

Product Classification:

Class II

Date Initiated: July 14, 2014

Date Posted: August 27, 2014

Recall Number: Z-2259-2014

Event ID: 68935

Reason for Recall:

Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.

Status: Terminated

Product Quantity: 6

Code Information:

Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.

Distribution Pattern:

Distributed in the states of: MA, NC, OH, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated