INTERSTIM 3093-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994601926), received between Jan 8, 2019 and Jun 30, 2025 — classified as 3 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (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.

• MalfunctionJun 30, 2025Difficult to Remove; Appropriate Device Problem Term/Code Not Available; Difficult to Remove; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY THINK LEAD FRAGMENT THAT REMAINED FROM THEIR PREVIOUS SYSTEM HAD MOVED FROM WHERE IT WAS BECAUSE THEY FOUND IT AFTER TAKING A SHOWER. THEY NEED AN MREI AND DON'T KNOW WHAT TO DO BECAUSE THE ABANDONED LEAD IS NOT MRI COMPATIBLE. AGENT REVIEWED UPDATED MRI GUIDELINES FOR ABANDONED PRODUCT WITH PATIENT, PATIENT STATED THAT THEIR ABANDONED FRAGMENT IS ABOUT AN INCH. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356648 ↗
• MalfunctionDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. THE CALLER REPORTED THAT THE PATIENT HAD THE INS REMOVED, BUT THE DOCTOR WAS UNABLE TO REMOVE THE LEAD. THEY HAD AN ABANDONED LEAD STILL IMPLANTED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9443733 ↗
• MalfunctionJan 8, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL (HCP) WHO HAD CALLED FOR MRI GUIDELINES THAT THE PATIENT HAD THE DEVICE EXPLANTED BUT THE TIP OF THE PLATINUM BASED ELECTRODE LEAD TIP WAS STUCK IN THE S3 FORAMEN. THERE WERE NO SYMPTOMS REPORTED AND IT WAS UNKNOWN WHEN THIS OCCURRED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8228528 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P970004. One submission often covers many models, so check the product and lot details in each record.

• 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-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