InterStim™ Micro 97810Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000913182), received between Mar 6, 2026 and May 6, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Charging Problem” (1 report).

7 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Electromagnetic Compatibility Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT MENTIONED THAT WHEN THEY WERE ABLE TO CHARGE THE INS IT FELT LIKE THEY WERE ALSO CHARGING THEIR [COMPETITOR] SPINAL CORD STIMULATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093390 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THERE WAS A POSSIBLE INFECTION. AT 1 MONTH POST OP VISITS NO SIGNS OF INFECTION. HEALTH CARE PROVIDER (HCP)  WAS MADE AWARE OF INFECTED AREA TODAY. ANTIBIOTICS GIVEN. (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT HAD AN INFECTION THAT WAS TREATED WITH ANTIBIOTICS. IT WAS UNKNOWN IF IT WAS RELATED TO THE DEVICE OR THERAPY. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED AS THE PATIENT HAD NOT FOLLOWED UP YET.

  Patient problems: Unspecified Infection

  MAUDE report 24642965 ↗
• InjuryMar 6, 2026Charging Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THEIR WIRELESS RECHARGER (WR) WAS NOT WORKING AND THAT THEY HAVEN'T BEEN ABLE TO CHARGE THEIR INS. PATIENT STATED THAT WHEN THEY PRESSED THE BUTTON ON THE WR, THERE WERE NO LIGHTS SHOWING. DURING THE CALL, PATIENT WAS VERY CONFUSING BECAUSE THEY WEREN'T SURE WHICH WAS THE WR'S POWER BUTTON. IT HAD BEEN A COUPLE FEW WEEKS SINCE THEY'D NOTICED THE ISSUE AND HAD BEEN TRYING TO GET THE WR WORKING. AGENT REVIEWED GENERAL DEVICE USE, BUT PATIENT WAS DISTRAUGHT AND DIDN'T SEEM TO BE FOLLOWING INSTRUCTIONS WELL. AGENT REVIEWED ROLE OF REP AND REDIRECTED THE PATIENT TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE, THEN SENT AN EMAIL TO THE FIELD FOR VISIBILITY. PATIENT ADDED THAT THEIR INS HADN'T BEEN WORKING YET, AND THAT THEY THOUGHT THEY'VE CHARGED THEIR INS AT ONE POINT. THEY COULDN'T CHARGE THEIR INS AT FIRST BECAUSE THEIR INCISION WAS INFECTED AND IT HURT TOO BAD.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 24530145 ↗

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-2365-2023 · Jul 6, 2023 · Open, Classified
  Medtronic InterStim Ground Pad REF 041826
• 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-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
• 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