InterStim™ 306001 (UDI 00763000295523)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00763000295523), received between Apr 8, 2021 and May 18, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Material Perforation

  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 STYLET WENT THROUGH THE TIP OF LEAD, BALL ON THE END DANGLING OFF SO LEAD COULDN'T BE IMPLANTED. THE LEAD SENT BACK FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202028 ↗
• MalfunctionAug 5, 2025Break; 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, VISUAL INSPECTION OF LEAD BY SURGEON AND FELLOW BEFORE INSERTING INTO PATIENT SHOWED A BROKEN METAL WIRE PIECE COMING OUT OF THE LEAD NEAR THE DISTAL ELECTRODE. PRODUCT DID NOT CONTACT THE PATIENT. THE LEAD SHOWED CLEAR SIGN OF WIRE BREAK STICKING OUT FROM NEAR THE ELECTRODE. LEAD REPLACED AND KEPT FOR ANALYSIS. NO CAUSE KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715989 ↗
• MalfunctionMay 22, 2024Difficult to Remove; Difficult to Remove

  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 DURING THE LEAD IMPLANT PROCEDURE YESTERDAY (B)(6) 2024 IT WENT AS EXPECTED, BUT WHEN THE DOCTOR WENT TO REMOVE THE STYLET FROM THE LEAD, IT WAS STUCK AND IT WOULDN'T COME OUT AT ALL. THE DOCTOR USED A DIFFERENT LEAD WITHOUT AN ISSUE. THEY INDICATED THAT THERE WAS NOTHING OBVIOUS WITH THE PRODUCT OR THE DOCTORS TECHNIQUE THAT WOULD EXPLAIN WHY THE STYLET WAS STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371902 ↗
• MalfunctionApr 30, 2024Break; Material Perforation; Break; Material Perforation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL LEAD. IT WAS REPORTED THAT THE SURGEON TAPPED THE TIP OF THE PNE LEAD TO ENSURE THAT THE STYLET WAS SEATED PROPERLY. THE STYLET THEN POKED OUT OF THE END OF THE LEAD AND LEAD WAS DAMAGED, BROKEN OR CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217447 ↗
• MalfunctionApr 30, 2024Material Perforation; Material Perforation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD. IT WAS REPORTED THAT THERE WAS AN OOB ISSUE. DURING THE PROCEDURE THE LEAD STYLET LOOKED TO PROTRUDE FROM THE END OF THE LEAD. THE CAUSE IS UNKNOWN. THE LEAD WILL BE RETURNED. TROUBLESHOOTING WAS PERFORMED. A NEW LEAD WAS OPENED. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217260 ↗
• InjuryJan 31, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. THE TRIAL STARTED ON 2024-01-24. IT WAS REPORTED THAT THE LEAD UNCOILED WHEN MD WAS REMOVING THE FORAMEN NEEDLE AND STYLET. LEAD WAS THEN REMOVED AND A NEW PNE LEAD WAS PLACED. CAUSE WAS NOT DETERMINED. THE ISSUE WAS CONFIRMED RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613148 ↗
• MalfunctionDec 19, 2023Component Missing; Component Missing

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THEY REPORTED THAT THE ISSUE WAS DISCOVERED AFTER THE BOX WAS OPEN BUT UNSURE IF BEFORE THE INDIVIDUAL PACKAGE WAS OPENED BY THE HEALTH CARE PROFESSIONAL. THERE IS NO ISSUE WITH DEVICE, THE PACKAGING WAS MISSING THE PNE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18355256 ↗
• MalfunctionDec 5, 2023Difficult to Insert; Material Perforation; Difficult to Insert; Material Perforation

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THEY STATED THE DEVICE WAS NEVER PLACED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268882 ↗
• MalfunctionNov 9, 2023Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND URGE INCONTINENCE. THEIR TRIAL START DATE WAS (B)(6) 2023. IT WAS REPORTED THAT THE LEAD WAS BROKEN. THE LEAD TIP WOULDN'T ADVANCE AND APPEARED TO HAVE GOTTEN STUCK IN THE NEEDLE. THE CAUSE WAS UNKNOWN. THIS HAPPENED TO A SECOND LEAD AS WELL. THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THEY STATED THAT THE PNE NEEDLE WAS INSERTED INTO THE FORAMEN OF THE PATIENT AND THE PHYSICIAN TRIED TO PUT THE LEAD INTO THE NEEDLE AND THE TIP GOT FLOPPY. THE MANUFACTURER REPRESENTATIVE (REP) BELIEVED IT WAS PHYSICIAN¿S ERROR AS THEY PULLED IT A BIT WITHOUT KNOWING SO THE STYLET WASN¿T ALL THE WAY IN IT AND THEREFORE THE TIP OF THE LEAD WAS TOO SOFT TO ADVANCE THROUGH. THE PHYSICIAN DID THIS TWICE. THE LEAD NEVER TOUCHED THE PATIENT; IT WAS IN THE HUB OF THE NEEDLE. THEY DID NOT KNOW THE LOT NUMBER OR PATIENT WEIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103956 ↗
• MalfunctionSep 8, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE DEVICE. IT WAS REPORTED THAT THE LEAD WAS OPENED FOR BACK TABLE TO PREP FOR A CASE. THE LEAD APPEARED DAMAGED AND WAS PROVIDED TO THE REP IMMEDIATELY. THERE WAS WHAT APPEARED TO BE AN EXTRA PIECE OF METAL HANGING OFF OF TIP OF LEAD. THE CAUSE WAS UNKNOWN. A NEW PRODUCT WAS OPENED TO REPLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712456 ↗
• MalfunctionAug 8, 2023Material Twisted/Bent; Break; Material Twisted/Bent; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE PATIENT'S INDICATION FOR USE WAS URGE INCONTINENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484200 ↗
• MalfunctionJul 27, 2023Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A LEAD. IT WAS REPORTED THAT THE LEAD UN-RAVELED AT DISTAL TIP FOLLOWING REMOVAL OF THE STYLET. STYLET WOULD NOT GO BACK INTO LEAD. ISSUE WAS DISCOVERED PRIOR TO CASE, NO PATIENT INVOLVEMENT. ACCOUNT DESTROYED THE LEAD AND IT WILL NOT BE COMING BACK FOR ANALYSIS. REP PULLED NEW LEAD FROM TRUNK, THERE WAS NO ISSUE OR CONCERNS WITH THIS LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17405758 ↗
• MalfunctionMay 9, 2023Material 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 THE PROXIMAL END OF THE LEAD WAS BENT WHICH RESTRICTED IF BEING REMOVED FROM THE NEEDLE. NEW KIT OPENED AND USED WITH NO ISSUES. TL 24 LOT NUMBER: 60379624.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16894876 ↗
• MalfunctionMar 6, 2023Break; Break

  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 16485546 ↗
• MalfunctionFeb 14, 2023Component Missing; Component Missing

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IN A P ROCEDURE TO BE IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING THE PROCEDURE THE PERCUTANEOUS NERVE EVALUATION (PNE) LEAD WAS MISSING THE ACTUAL LEAD. THE SCRUB NURSE REMOVED THE LEAD FROM THE PLASTIC TUBING AND DISCOVERED THAT ONLY A STYLET WAS IN THE TUBING, NO ACTUAL LEAD. THE CAUSE IS UNKNOWN. THERE IS NO PATIENT INVOLVED IN THIS EVENT. THE STYLET WILL BE RETURNED. THE REP CLARIFIED THAT THE PATIENT WAS NOT THERE TO HAVE AN INS IMPLANTED. PATIENT WAS THERE FOR A PNE TO TREAT URGENCY/FREQUENCY, THIS WAS THE PERC TEST TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16373587 ↗
• MalfunctionJan 6, 2023Break; Difficult to Insert; Device Contaminated During Manufacture or Shipping; Break; Difficult to Insert; Device Contaminated During Manufacture or Shipping

  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 THERE WAS AN OUT OF THE BOX ISSUE, THE PNE LEAD HAD A BARB OR PIECE OF METAL STICKING OUT OF THE TIP OF THE LEAD TO THE SIDE SO THAT THE LEAD WOULD NOT ADVANCE THROUGH THE NEEDLE. TROUBLESHOOTING WAS NOT REQUIRED. CALLER HAS LEAD TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113663 ↗
• MalfunctionDec 5, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER). IT WAS REPORTED THAT WHEN THE SUR GEON TOOK THE PNE LEAD OUT OF THE PACKAGING THE TIP OF THE LEAD THAT WAS OUT OF THE SHEATH WAS BENT. THE SURGEON ATTEMPTED TO STRAIGHTEN TIP BUT IT REALLY WOULD NOT STRAIGHTEN AND THEN SHEATH STARTED TO PEEL AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920787 ↗
• InjuryNov 30, 2022Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS IN A PROCEDURE TO BEGIN USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE. IT WAS NOTED THAT THE PATIENT'S TRIAL STARTED ON (B)(6) 2022. IT WAS REPORTED THAT DURING SURGERY THE STYLET COULD NOT BE REMOVED FROM THE LEAD FOLLOWING THE NEEDLE EXCHANGE. THE HEALTHCARE PROVIDER (HCP) FOLLOWED THE CORRECT STEPS TO REMOVE THE BLUE PLASTIC PIECE, THEN THE STYLET, WHICH WAS STUCK IN THE LEAD AND JUST KEPT PULLING THE LEAD BUT COULD NOT BE REMOVED. THE LEAD HAD TO BE WASTED AND REMOVED FROM THE PATIENT AND A NEW NEEDLE/LEAD NEEDED TO BE INSERTED. THE CAUSE IS UNKNOWN. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886777 ↗
• MalfunctionAug 24, 2022Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGE INCONTINENCE. IT WAS REPORTED THAT LEAD TIP WAS PULLED OFF STYLET AND PUNCTURED AND WAS UNABLE TO MOVE BACK UNTIL STYLET. AS A RESULT, IT WAS UNUSABLE AS IT WOULDN¿T PROCEED THROUGH THE NEEDLE. CAUSE WAS NOT DETERMINED. THE ISSUE WAS CONFIRMED RESOLVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282143 ↗
• MalfunctionJul 6, 2022Break; Difficult to Insert; Material Deformation; Break; Difficult to Insert; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGENCY FREQUENCY. IT WAS REPORTED THAT THE LEAD STYLET WOULD NOT ADVANCED TO THE TIP OF THE LEAD. THE PHYSICIAN ATTEMPT TO STIFFEN LEAD BY ADVANCING THE STYLET RESULTED IN THE LEAD TIP GETTING BENT AND UNABLE TO ADVANCE INTO THE HEAD OF THE NEEDLE FOR PLACEMENT. THE LEAD WAS BROKEN, DAMAGED OR CUT. LEAD WAS REPLACED BY REP TRUNK STOCK ITEM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14930915 ↗
• InjuryMar 24, 2022Break; Difficult to Remove; Break; Difficult to Remove

  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 THERE WAS AN OUT OF BOX ISSUE. THE CALLER STATES THAT SHE WAS IN THE CASE TODAY FOR PNE WITH ADAPTOR. CALLER STATES THAT THE LEAD THAT CAME IN THE KIT PERFORMED GREAT. CALLER STATES THAT THE LEAD THAT WAS IN THE SEPARATE BOX COMPLETELY UNRAVELED WHEN THE DOCTOR TOOK THE NEEDLE OUT AND WAS TRYING TO LIFT THE NEEDLE AND SHEATHE OUT AND LEAVE THE LEAD IN THE PATIENT. CALLER STATES IT GAVE HIM SOME RESISTANCE AND THEN 'LITERALLY COMPLETELY FELL APART'. THE HCP WANTS A WHOLE NEW PNE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13890137 ↗
• MalfunctionFeb 3, 2022Break; Difficult to Insert; Break; Difficult to Insert

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL LEAD. IT WAS REPORTED THAT THE BASIC EVALUATION LEAD WAS DAMAGED AT THE END BY THE ELECTRODES FRESH OUT OF THE PACKAGE. THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE, AND THE PACKAGE WAS NOT DAMAGED THAT IT WAS DELIVERED IN. THE ELECTRODES AND TINES WERE ALL CONVOLUTED AT THE END, SO THE LEAD WOULD NOT ADVANCE DOWN THE NEEDLE FORAMEN DURING A BASIC EVALUATION. IT DID NOT FIT BECAUSE IT WAS DAMAGED. A NEW BASIC EVALUATION LEAD WAS OPENED AND USED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446916 ↗
• MalfunctionJan 28, 2022Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A TRIAL PATIENT FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT BASIC EVALUATION LEAD STYLET WAS BENT AT THE TIP, THEREFORE THE LEAD WAS NOT ABLE TO BE PLACED. PHYSICIAN TRY TO STRAIGHTEN THE STYLET AND THREAD THE LEAD OVER IT WITHOUT SUCCESS. TSS RETRIEVED A BASIC EVALUATION LEAD FROM TRUCK STOCK TO USE. THERE WAS NO SURGICAL INTERVENTION THAT OCCURRED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388646 ↗
• MalfunctionApr 8, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE DEVICE WAS DISCARDED AND HCP WAS NOTIFIED OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636862 ↗
• MalfunctionApr 8, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  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 UPON INSERTION OF THE PNE LEAD IT WAS NOTICED THAT THERE ARE NO DEPTH MARKERS ON THE LEAD. THEY PERFORMED TWO PNE PROCEDURES. DURING THE FIRST PNE, IT WAS NOTICED THAT THEY WERE ABLE TO SLIGHTLY SEE A HINT OF WHAT LOOKED LIKE A DEPTH MARKER AND PROCEEDED TO USE THE PNE LEAD. DURING THE SECOND PNE, THEY NOTICED IT AGAIN. THEY OPENED A NEW PNE LEAD AND STILL SAW NO DEPTH MARKER. ALL OF THE PNE LEADS MISSING DEPTH MARKERS ARE FROM THE SAME LOT BATCH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636710 ↗

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