Medtronic Neuromodulation: Medical Device Recall in 2015 - (Recall #: Z-1147-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy. The neurostimulators are multiprogrammable devices that accommodates a lead through which a stimulation program is delivered. The Medtronic Enterra Neurostimulator, Model 3116, is part of an Enterra Therapy system for gastric electrical stimulation (GES). The neurostimulator is a multiprogrammable device that accommodates a lead through which a stimulation program is delivered.

Product Classification:

Class II

Date Initiated: January 9, 2015

Date Posted: March 4, 2015

Recall Number: Z-1147-2015

Event ID: 70271

Reason for Recall:

Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.

Status: Terminated

Product Quantity: 396,975 (258,805 USA, 138,170 OUS)

Code Information:

All lot/serial numbers are affected for all 4 Model numbers: " Model 7425 " Model 3058 " Model 3023 " Model 3116

Distribution Pattern:

Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada

Voluntary or Mandated:

Voluntary: Firm initiated