Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 4, 2015
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 sti
Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device ba…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Neuromodulation recalled The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designe… - a moderate-severity action.
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designe… was recalled by Medtronic Neuromodulation in March 4, 2015. Reason: Current labeling indicates that cycling improves device longevity in every programming scenario. However, ena…. Check the official notice for the remedy. Verify recall #Z-1147-2015 with the FDA Devices before acting.
The recall
Medtronic Neuromodulation issued this moderate-severity FDA Devices recall-Current labeling indicates that cycling improves device longevity in every programming scenario. However, ena….
- Moderate
- severity level
- Class II
- classification
- March 4, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1147-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1147-2015) was formally reported on March 4, 2015, with the manufacturer initiating the action on January 9, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Neuromodulation is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 396,975 (258,805 USA, 138,170 OUS).
The documented reason for this recall is: 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, l… Distribution data in the federal record shows the product reached: Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
396,975 (258,805 USA, 138,170 OUS)
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1147-2015 |
| Date reported | March 4, 2015 |
| Date initiated | January 9, 2015 |
| Recalling firm | Medtronic Neuromodulation |
| Firm location | Minneapolis, MN |
| Affected scope | 396,975 (258,805 USA, 138,170 OUS) |
| Distribution | Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1147-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Neuromodulation. Units affected: 396,975 (258,805 USA, 138,170 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2015. Severity: Moderate. Recall number: Z-1147-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1147-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 4, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.