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InterStim™ 041826Recalls & reported problems

Medtronic, Inc. · ACCY 041826 INTRSTIM GROUND PAD GLBL MDR · Class 3

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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, 1 still open.

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

  1. Jul 6, 2023Open, Classified

    Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.

    Z-2365-2023 · Root cause: Under Investigation by firm · 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, Classified
    Enhanced Verify Evaluation Handset (CFN HH90130FA)
  • Z-0372-2025 · Sep 18, 2024 · Open, Classified
    Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
  • Z-0998-2022 · Feb 28, 2022 · Terminated
    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA,
  • Z-1147-2015 · Jan 9, 2015 · Terminated
    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 m
  • Z-0037-2008 · Jun 25, 2007 · Terminated
    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. Implanta
  • Z-0040-2008 · Jun 25, 2007 · Terminated
    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

Other Stimulator, electrical, implantable, for incontinence devices

All Stimulator, electrical, implantable, for incontinence devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.