Medtronic InterStim INS (Model 3023) with N'Vision Inter… recallZ-0040-2008 · Medtronic Neuromodulation · initiated Jun 25, 2007
Terminated All recalls posted in October 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 (Model 3037).
FDA root cause category: Software design
What the company is doing
Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient management for the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail.
Recall details
- Recall number
- Z-0040-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 25, 2007
- Posted by the FDA
- Oct 12, 2007
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1885
- Product code
- EZW
- FDA submissions
- P970004
- Distribution
- Nationwide and the Netherlands.
Product description
Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.
Code information (models, lots, serial numbers)
All serial numbers within these catalog/model numbers are affected (Model 3023, Catalog Number 8870MMB01 and 8870NNB01)
Other devices under the same FDA submission
60 devices cleared under P970004 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- INTERSTIM® 3058Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence6 deaths23,065 reports
- InterStim™ X 97800Medtronic, Inc. · Implanted electrical device intended for treatment of fecal incontinence5,930 reports
- InterStim™ Micro SureScan™ 97810Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence2,757 reports
- InterStim™ X 97800Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence1,822 reports
- INTERSTIM® II 3058Medtronic, Inc. · Implanted electrical device intended for treatment of fecal incontinence990 reports
- INTERSTIM® 3058Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence817 reports
- INTERSTIM® 3023Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence1 death147 reports
- INTERSTIM® 3023Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence110 reports
- N/A TH90G01Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence2 recalls0 reports
- N/A TH90GFAMedtronic, Inc. · Stimulator, electrical, implantable, for incontinence2 recalls0 reports
- InterStim™ SureScan™ 978B128Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence58 reports
- Verify® External Neurostimulator 353101Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence58 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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