FDA Device recall Z-1147-2015
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervou…
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervou… by Medtronic Neuromodulation, citing current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device ba….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1147-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-09 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | All lot/serial numbers are affected for all 4 Model numbers: " Model 7425 " Model 3058 " Model 3023 " Model 3116 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1147-2015%22
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