INTERSTIM® 3093-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994752390), received between Jun 16, 2021 and Oct 2, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse 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 GASTROINTESTINAL/PELVIC FLOOR THERAPY AND FECAL INCONTINENCE. IT WAS REPORTED THAT DURING THE REPLACEMENT OF A NEUROSTIMULATION SYSTEM A LEAD FRAGMENT WAS LEFT BEHIND. THE MANUFACTURING REPRESENTATIVE (REP) INQUIRED ABOUT MRI STATUS WITH THE  LEAD FRAGMENT. TECHNICAL SERVICES REDIRECTED THEM TO THE OFFICE OF MEDICAL AFFAIRS TO GET LITERATURE ON THE TOPIC. THE REP SAID AN HCP WAS ASKED TO REMOVE THE LEAD FRAGMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17852951 ↗
• MalfunctionJun 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY RECEIVED A CALL FROM HCP AT FOUNDATION NEUROLOGY TODAY (B)(6)2022, THEY MENTIONED DURING THE CALL THAT THEY WERE INFORMED THAT PATIENT'S LEAD IN (B)(6) 2014 WAS FRAYED AND MIGHT HAVE BEEN REPLACED ON (B)(6) 2017 BUT THEY DO NOT HAVE ANY FURTHER INFORMATION ABOUT IT. THEY WILL CALLBACK ONCE THEY HAVE VERIFIED AND HAVE THE INFORMATION TO UPDATE PATIENT'S RECORD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569358 ↗
• MalfunctionJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE INS HAD BEEN REMOVED, BUT THE LEAD WAS LEFT IMPLANTED UNINTENTIONALLY. IT WAS NOTED THEY TRIED TO REMOVE IT, BUT COULDN'T. IT WAS NOTED THE PATIENT HAD SINCE BEEN IMPLANTED WITH A WHOLE NEW SYSTEM. ADDITIONAL INFORMATION REPORTED IT APPEARED THE TINES PULLED OUT, BUT A PORTION OF THE LEAD DID NOT PER CLINICAL NOTE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12008590 ↗

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-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