NA A51300Recalls & reported problems
Medtronic, Inc. · SW APP A51300 OASIS CLINICIAN GU · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
6 other recalls cover devices cleared under the same FDA submission (P080025, P970004); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Feb 28, 2022Terminated
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.
Z-0998-2022 · Root cause: Software Design Change · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P080025, P970004. One submission often covers many models, so check the product and lot details in each record.
- Z-1704-2025 · Apr 3, 2025 · Open, ClassifiedEnhanced Verify Evaluation Handset (CFN HH90130FA)
- Z-0372-2025 · Sep 18, 2024 · Open, ClassifiedMedtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
- Z-2365-2023 · Jul 6, 2023 · Open, ClassifiedMedtronic InterStim Ground Pad REF 041826
- Z-1147-2015 · Jan 9, 2015 · TerminatedThe 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 m
- Z-0037-2008 · Jun 25, 2007 · TerminatedMedtronic 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. Implanta
- Z-0040-2008 · Jun 25, 2007 · TerminatedMedtronic 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
Other Stimulator, electrical, implantable, for incontinence devices
- INTERSTIM® 3058Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence6 deaths23,065 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® 3058Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence817 reports
- Axonics 4101Axonics Modulation Technologies, Inc. · Stimulator, Electrical, Implantable, For Incontinence1 death801 reports
- Axonics 1101Axonics Modulation Technologies, Inc. · Stimulator, Electrical, Implantable, For Incontinence1 death397 reports
- Axonics 5101Axonics Modulation Technologies, Inc. · Stimulator, Electrical, Implantable, For Incontinence162 reports
- INTERSTIM® 3023Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence1 death147 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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