INTERSTIM® 3889-33 (UDI 00613994752437)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994752437), received between Apr 22, 2017 and Aug 9, 2019 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionAug 9, 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 VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. WHEN THE LEAD WAS EXPLANTED THE ELECTRODES REMAINED IN THE BODY. THEY WERE DETACHED FROM THE LEAD. THEY WERE STILL IN THE PATIENT AND THERE WERE NO PLANS TO REMOVE THEM. THERE WERE NO CONTRIBUTING FACTORS REPORTED, NO DIAGNOSTICS PERFORMED AND NO ACTIONS TAKEN AT THE TIME OF THE REPORT. IT WAS REPORTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8878882 ↗
• MalfunctionNov 20, 2018Labelling, Instructions for Use or Training Problem; Peeled/Delaminated; Device Damaged Prior to Receipt by User; Labelling, Instructions for Use or Training Problem; Peeled/Delaminated; Device Damaged Prior to Receipt by User

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING LEAD. IT WAS REPORTED THAT AS THE LEAD WAS EXAMINED DURING PROCEDURE THE LEAD AND THE EXTERIOR COATING/INSULATION HAD CLEARLY SEPARATED FROM THE MOST DISTAL END OF THE PROXIMAL ELECTRODES. THEY NOTICED THE DAMAGED OF THE LEAD AND WAS REPLACED. THEY OPENED A NEW LEAD KIT AND USE THE NEW LEAD. NO SIGNS OR SYMPTOMS AS WE REPLACED THE LEAD DURING THE PROCEDURE. THE ISSUE WAS RESOLVED AT THE TIME OF THIS CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8089982 ↗
• InjuryApr 22, 2017Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HAD THEIR LEAD REPLACED ON THE DAY OF THE REPORT. IT WAS NOTED THAT THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Electric Shock; No Known Impact Or Consequence To Patient; Pain

  MAUDE report 6513704 ↗

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