INTERSTIM® 305901 (UDI 00613994925947)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994925947), received between May 30, 2017 and Oct 2, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2017Bent; Device Damaged Prior to Receipt by User; Bent; Device Damaged Prior to Receipt by User

  THE 2A MANUFACTURING REPRESENTATIVE (REP) REPORTED ON BEHALF OF A HEALTHCARE PROVIDER (HCP) THAT UPON TAKING THE LEAD OUT OF THE PACKAGING, THE HCP NOTICED, BEFORE ATTEMPTING TO IMPLANT, THAT THE DISTAL TIP (~.5 CM FROM THE END) HAD A BEND IN IT. HE BRIEFLY TESTED TO SEE IF IT WOULD GO IN THE NEEDLE TROCAR TO SEE, BUT AS SUSPECTED, IT WOULD NOT PASS. A DIFFERENT LEAD WAS USED INSTEAD. THERE WERE NO PATIENT SYMPTOMS OR AFFECTS ASSOCIATED WITH THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6907516 ↗
• MalfunctionMay 30, 2017Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE LEAD KINKED WHILE THE HEALTHCARE PROFESSIONAL (HCP) WAS PLACING THE LEAD THROUGH THE FORAMEN NEEDLE. ONCE KINKED, THE LEAD WOULDN'T PROPERLY FEED THROUGH THE NEEDLE. IT WAS REPLACED WITH A NEW LEAD AND THE ISSUE WAS RESOLVED. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6599807 ↗

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