InterStim™ 041839Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000114064), received between Aug 16, 2021 and Aug 16, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 2021-AUG-12 (B)(4) (REP, HCP, FOR): INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT PATIENT WAS ADMITTED FOR ROUTINE STAGE 1 TINED LEAD SACRAL NEUROMODULATION TRIAL. SURGEON HAD A LOT OF DIFFICULTY LOCATING CORRECT AREA WITH THE NEEDLES PROVIDED (THE 1ST STEP OF THE PROCEDURE). JUST BEFORE END OF SURGERY WAS ABANDONED SURGEON REQUESTED LONG NEEDLES TO BE OPENED. THE BOX WAS GIVEN TO THE SCOUT NURSE AND THE EXPIRY DATE WAS CHECKED OUT LOUD. NO ONE REALIZED THE EXPIRY DATE WAS 5/8/2021. THE DATE OF SURGERY WAS (B)(6) 2021. THE ANESTHETIST BY THIS STAGE HAD ALSO SCRUBBED IN TO THE CASE AND WAS ATTEMPTING TO LOCATE THE CORRECT PLACE WITH THE EXISTING NEEDLES. VERY SOON AFTER THIS THE SURGEON ABANDONED THE CASE. THERE IS NO GUARANTEE THAT THE LONG NEEDLES WERE USED IN THE PATIENT AS THERE WERE MULTIPLE NEEDLES AVAILABLE ON THE TROLLEY AND 2 DOCTORS BY THIS STAGE. UNFORTUNATELY DUE TO EXTREME WORK STRESS, RECENT COVID 19 ISOLATION AND A SORE BACK I HAD NOT NOTICED THE NEEDLES HAD EXPIRED BY 4 DAYS. THE HOSPITAL STAFF HAD NOT NOTICED EITHER DESPITE THE STAFF CHECKING THE DATE. PRIOR TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12328193 ↗

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