Z-1147-2015 Class II Terminated
FDA device recall Z-1147-2015 was initiated by Medtronic Neuromodulation on Jan 9, 2015 and is designated Class II. 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… The recall status is terminated (terminated Sep 28, 2017). Affected quantity: 396,975 (258,805 USA, 138,170 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 4, 2015
- Initiation Date
- Jan 9, 2015
- Termination Date
- Sep 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 396,975 (258,805 USA, 138,170 OUS)
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.
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.
Distribution Pattern
Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada
Code Information
All lot/serial numbers are affected for all 4 Model numbers: " Model 7425 " Model 3058 " Model 3023 " Model 3116
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1147-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026