InterStim™ 309201 (UDI 00763000295547)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000295547), received between Dec 16, 2021 and Mar 2, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break; Difficult to Insert

  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 THE LEAD TIP CAME OUT OF THE BOX DAMAGED. IT WAS REPORTED THE LEAD TIP WOULD NOT PASS THROUGH THE FOREMAN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482135 ↗
• MalfunctionJan 22, 2026Difficult to Remove

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE ELECTRODE GUIDE DID NOT REMOVE. NOT USED/IMPLANTED. WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153057 ↗
• MalfunctionJul 31, 2025Break; Migration or Expulsion of Device; Insufficient Device Problem Information; Break; Migration or Expulsion of Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE X-RAY HAS BEEN DONE AND NO LEAD FRAGMENTS TO BE SEEN THEREFORE NO FURTHER ACTION TO BE TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22676580 ↗
• MalfunctionMar 11, 2025Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT PHYSICIAN WAS DOING A BASIC TRIAL AND WENT TO PULL THE STYLET OUT AND THE LEAD WAS JUST UNCOILING AROUND THE STYLET. IT WOULD NOT RELEASE PROPERLY. THE DECISIONS WAS MADE TO REPLACE THE LEAD. UNKNOWN CAUSE. THE STYLET WOULD NOT REMOVE FROM LEAD EASILY, NOT OTHER TROUBLE SHOOTING COULD BE DONE AS THE LEAD JUST WAS UNCOILING. ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21578282 ↗
• MalfunctionJan 24, 2025Break; Difficult to Remove; Break; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENTS INDICATION FOR USE WAS FOR URGE INCONTINENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21231310 ↗
• MalfunctionJul 12, 2024Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT UPON REMOVING LEAD FROM PACKAGING, THE TIP WAS BENT. NEVER IMPLANTED, AND WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733777 ↗
• MalfunctionMay 9, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE HEALTHCARE PROFESSIONAL (HCP) OPENED THE BASIC EVALUATION ELECTRODE FOR THE FIRST TIME, THEY FOUND AN ELECTRODE DAMAGE IN THE FINAL PART. NO CAUSE KNOWN. A DIFFERENT ELECTRODE WAS USED. DAMAGED ELECTRODE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282753 ↗
• MalfunctionMar 5, 2024Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS UNDERG OING A TRIAL PROCEDURE FOR PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE BASIC EVALUATION LEAD GOT BENT DURING INSERTION, DOCTOR COULD NOT GET THE LEAD TO GO THROUGH THE NEEDLE. THEY ATTEMPTED TO RE-INSERT THE STYLET, BUT COULD NOT. THE HCP USED ANOTHER LEAD AND PROCEDURE WAS COMPLETED WITHOUT ISSUE TO RESOLVE THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) STATED THE CAUSE WAS UNKNOWN. IT IS UNKNOWN, THE LEAD COULD HAVE BEEN HANDLED IMPROPERLY BY THE MA, HOWEVER THEY¿VE USED SEVERAL OF THESE LEADS WITHOUT ISSUE. THE MA TOOK THE LEAD DURING THE CASE AND PUT IT IN THE HAZARDOUS WASTE SHARPS CONTAINER AND IT WILL NOT BE RETURNED. THE PHYSICIAN DID NOT KNOW THE INFORMATION EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836767 ↗
• MalfunctionMar 5, 2024Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD THAT OCCURRED DURING A TRIAL PROCEDURE. IT WAS REPORTED THAT THE LEAD WOULD NOT GO THROUGH THE 18G CATHETER. TROUBLESHOOTING WAS PERFORMED. WE TRIED TO ADJUST THE STYLET AND RE-THREAD THE LEAD ONTO IT. TRIED MULTIPLE TIMES TO ADVANCE THE LEAD. THE NEEDLE WAS INSERTED TO BE SURE NOTHING WAS BLOCKING THE CATHETER TRACK BUT INSERTED AND PULLED OUT AS IT SHOULD. TRIED THE LEAD WITH ANOTHER FORAMEN NEEDLE BUT WOULD NOT ADVANCE. THE CAUSE IS UNKNOWN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THEY STATED THAT WHEN THEY SAID "CATHETER", THEY WERE REFERRING TO THE FORAMEN NEEDLE WITH THE INNER STYLET OUT OF IT. AND FOR THE NEEDLE THEY WERE REFERRING TO THE STYLET OR PINK HUB PIECE THAT GOES INTO THE OPEN TUBE TO COMPLETE THE FORAMEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836629 ↗
• InjuryFeb 6, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY. THEIR TRIAL START DATE WAS (B)(6) 2023 . IT WAS REPORTED THAT THE LEAD BROKE DURING TRIAL PROCEDURE. THE ISSUE WAS ONGOING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE LEAD BROKE DURING THE INSERTION/REMOVAL/REINSERTION PROCESS. THE CAUSE OF THE LEAD BREAKING WAS UNKNOWN BUT THEY PROVIDED A MOST LIKELY CAUSE OF PHYSICIAN ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18653146 ↗
• MalfunctionJul 7, 2023Difficult to Insert; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WHO RECEIVED AN ENS (EXTERNAL NEUROSTIMULATOR) FOR URGE INCONTINENCE. IT WAS NOTED THE PATIENT'S TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT THE HCP COULD NOT GET THE LEAD TO THREAD AND DECIDED TO OPEN A NEW ONE. THE HCP ATTEMPTED TO INSERT THE GUIDEWIRE TO THE END OF THE LEAD. THE LEAD SEEMED TO BE DEFECTIVE FROM THE PACKAGING AND WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17282485 ↗
• MalfunctionMar 6, 2023Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WHO WAS IN A PROCEDURE PRIOR TO USE OF AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY AND URGE INCONTINENCE. IT WAS NOTED THAT THE PATIENT'S TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT DURING THE PROCEDURE THERE WAS A PRODUCT ISSUE WITH THE LEAD. THE MARKINGS ON THE TEMPORARY LEAD WERE HARD TO SEE ON ONE OF THE LEADS PLACED. THE OTHER LEAD HAD THE MARKINGS BUT IT COULD NOT BE CONFIRMED WHAT KIT THE LEAD CAME FROM, WHETHER IT WAS FROM THE 309201 KIT OR THE 306001 KIT SO THE REP ADDED BOTH ON THE REPORT. THE CAUSE IS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. THE PHYSICIAN PLACED THE LEAD UNTIL RESISTANCE WAS FELT AND THEN TESTED THE LEAD. AN APPROPRIATE RESPONSE FROM THE LEAD WAS RECEIVED WHEN STIMULATING IT. THE ISSUE IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485533 ↗
• MalfunctionNov 9, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY. IT WAS REPORTED THAT THERE WAS A LEAD ISSUE DURING SURGERY. THE LEAD TIP WAS BENT. THE LEAD WAS NEVER IMPLANTED AND WILL BE RETURNED. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759552 ↗
• MalfunctionNov 7, 2022Break; Break

  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 THE PNE LEAD WAS VISIBLY DEFECTIVE OUT OF THE BOX. NO PATIENT WAS INVOLVED. CAUSE WAS NOT KNOWN AND TROUBLESHOOTING WAS NOT PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15743915 ↗
• MalfunctionJun 27, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT CALLER STATED THEY ATTENDED PNE TRIAL TODAY IN WHICH THEY HAD TWO DEFECTIVE LEADS. THE FIRST LEAD, IT APPEARED THE STYLET WASN'T LONG ENOUGH OR BENT SO THE DISTAL TIP OF THE LEAD WAS "FLOPPY" AND THEY WEREN'T ABLE TO ADJUST IT. THE SECOND LEAD HAD A SIMILAR ISSUE IN WHICH THE STYLET HAD COME OUT THE SIDE OF THE LEAD NEAR THE SILVER PART AT THE DISTAL END - LIKE IT HAD PUSHED THROUGH THE LEAD. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE CALLER WAS WARM TRANSFERRED TO CUSTOMER SERVICE. CALLER STATED ACCOUNT USED TWO OF THEIR EXTRA LEADS THEY HAD WITHOUT ISSUE. CALLER WILL BE RETURNING LEADS. CALLER MENTIONED THEY'VE NEVER HAD TO RETURN PNE LEADS BEFORE - ONLY IMPLANTABLE LEADS. TSS DIDN'T ASK FURTHER QUESTIONS ABOUT THIS COMMENT AND REVIEWED THEY CAN USE SAME RETURN MAILER KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828431 ↗
• MalfunctionJun 7, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGENCY FREQUENCY. IT WAS REPORTED THAT A COATING CAME OFF THE 5¿ NEEDLE IN THE PNE KIT AFTER USE. THE HCP SAID SHE HAS BEEN HITTING BONE. THE ITEM WAS DISPOSED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP CLARIFIED THAT THIS WAS NOT AN OUT OF THE BOX ISSUES. THE HEALTHCARE PROVIDER (HCP) WAS USING THE 5¿ NEEDLE TO LOCATE THE S3 FORAMEN AND WHILE DOING SO NOTICED THAT THERE WAS SOMETHING ON THE 5¿NEEDLE. THIS EVENT OCCURRED IN THE PNE PROCEDURE PRIOR TO PLACING THE LEADS AND CONNECTING THE ENS. WHILE TRYING TO LOCATE THE S3 FORAMEN THE HCP WAS UNABLE TO GET IN THE FORAMEN AND THE NEEDLE WAS SCRAPPING AGAINST OR HITTING BONE. AFTER MULTIPLE ATTEMPTS TO FIND S3, SHE REMOVED THE NEEDLE AND NOTICED THAT THERE APPEARED TO BE A COATING OR SOMETHING COMING OFF THE NEEDLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621048 ↗
• MalfunctionDec 16, 2021Difficult to Insert; Material Twisted/Bent; Insufficient Device Problem Information; Difficult to Insert; Material Twisted/Bent; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA REP REGARDING A PATIENT WITH AN EXTERNAL DEVICE (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE LEAD MALFUNCTION, TIP WOULD NOT STAY STRAIGHT FOR THE INSERTION TO THE FORAMEN NEEDLE. THEY ATTEMPTED TO RELOAD STYLET TO NO AVAIL. THERE WAS NO SURGICAL INTERVENTION THAT OCCURRED. THE LEAD WAS REPLACED AND THE REPORTED ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019487 ↗

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