Medtronic InterStim II INS Model 3058 with N'Vision… recallZ-0037-2008 · 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
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 .
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 mangement of 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-0037-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 25, 2007
- Posted by the FDA
- Oct 11, 2007
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1885
- Product code
- EZW
- FDA submissions
- P970004
- Distribution
- Nationwide and the Netherlands.
Product description
Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.
Code information (models, lots, serial numbers)
All serial numbers within these catalog/model numbers are affected: Model 3058, Catalog # 8870MM01 & 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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