PMA · Approved
Recalled · Class II · 2024Medtronic Interstim Therapy System for Urinary Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Neuromodulation · EZW Stimulator, Electrical, Implantable, For Incontinence
Approved on Sep 29, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 242-day review. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Sep 29, 1997
- Review
- 242 days
- Class
- Class III
- Product code
- EZW
- Recalls
- 5
1 later device descends from it, 1 citing it directly.
- This deviceP970004 Medtronic Interstim Therapy System for Urinary ControlMedtronic Neuromodulation · 1997
- Descendant · cites it directly · 0 of its ownK013063 Grip Lock Anchor, Model 411374Medtronic Neurological · 2001
Most influential descendants
Showing 1 of 1 · See all- K013063Grip Lock Anchor, Model 411374Medtronic Neurological · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P970004 | Medtronic Interstim Therapy System for Urinary Control | Medtronic Neuromodulation | 1997 | — |
| +1 | K013063 | Grip Lock Anchor, Model 411374 | Medtronic Neurological | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013063 | Grip Lock Anchor, Model 411374 | 2001 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2024 | Class II | Z-0372-2025 | Under Investigation by firm | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. |
| Feb 28, 2022 | Class II | Z-0998-2022 | Software Design Change | There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed. |
| Jan 9, 2015 | Class II | Z-1147-2015 | Other | 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… |
| Jun 25, 2007 | Not classified | Z-0040-2008 | Software design | Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer… |
| Jun 25, 2007 | Not classified | Z-0037-2008 | Software design | A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant . |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K013063 (Medtronic Neurological, 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EZW devicesEZW Stimulator, Electrical, Implantable, For Incontinence: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZW
36in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZW
Too few EZW 510(k)s in any year since 2007 to give a median.
Recalls per year · EZW
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZW
6,956in 2025
MAUDE reports naming product code EZW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | — | 2 | 168 |
| 2008 | 14 | — | 1 | 724 |
| 2009 | 12 | — | 0 | 1,012 |
| 2010 | 24 | — | 0 | 1,425 |
| 2011 | 26 | — | 0 | 1,610 |
| 2012 | 19 | — | 0 | 2,815 |
| 2013 | 17 | — | 0 | 3,736 |
| 2014 | 23 | — | 0 | 4,603 |
| 2015 | 20 | — | 0 | 5,977 |
| 2016 | 27 | — | 0 | 7,083 |
| 2017 | 27 | — | 0 | 8,097 |
| 2018 | 19 | — | 0 | 5,737 |
| 2019 | 24 | — | 0 | 4,772 |
| 2020 | 43 | — | 0 | 4,118 |
| 2021 | 34 | — | 1 | 4,479 |
| 2022 | 46 | — | 1 | 4,318 |
| 2023 | 32 | — | 0 | 5,056 |
| 2024 | 35 | — | 1 | 5,773 |
| 2025 | 36 | — | 0 | 6,956 |
| 2026 | 37 | — | 1 | — |
https://510kreport.com/device/P970004 · printed Nov 6, 2026
Cite this page
510(k) Report. “P970004: Medtronic Interstim Therapy System for Urinary Control.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970004
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026