INTERSTIM® 3889-28 (UDI 00643169864436)Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00643169864436), received between Jun 26, 2018 and Jul 9, 2025 — classified as 26 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Break” (34 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE MOST LIKELY CAUSE OF THE PATIENT NO LONGER FEELING STIMULATION WAS THE RESULT OF THE BATTERY REACHING END OF SERVICE (EOS), AS DETERMINED BY THE PATIENT'S HCP. WHEN THE HCP INTERROGATED THE BATTERY, THE PATIENT DIDN'T MENTION ANYTHING TO THE HCP ABOUT BEING INVOLVED IN A CAR ACCIDENT. THE PATIENT STATED THAT PRIOR TO THE CAR ACCIDENT, THEIR SYMPTOMS HAD STARTED TO RETURN, WHICH WAS ATTRIBUTED TO THE BATTERY LIFE. THE REP STATED THE PATIENT HAD THEIR BATTERY REPLACED ON (B)(6) 2025, AND THE IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PATIENT FELT NO SENSATION POST-OP WHEN THERAPY WAS TURNED ON (TESTED UP TO 8.0 MA). THE REP FOLLOWED UP WITH THE PATIENT 48 HOURS LATER AND THEY WERE STILL NOT FEELING SENSATION AND IT WAS AT THIS TIME THE PATIENT SHARED THEY WERE INVOLVED IN A CAR ACCIDENT IN (B)(6). THE REP STATED AN ANTEROPOSTERIOR (AP) AND LATERAL X-RAY WERE ORDERED BY THE PATIENT'S HCP, AND THE PATIENT HAD A FOLLOW-UP APPOINTMENT SCHEDULED WITH THEIR HCP ON (B)(6) 2025. THE REP STATED, THE CAUSE OF THERAPY NOT WORKING WAS THE RESULT OF THE BATTERY REACHING EOS, AND THE X-RAYS WER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22460434 ↗
• MalfunctionNov 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  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 THERE WAS A REPORT ON LEAD INTEGRITY. THE HCP NOTICED MARKS ON LEAD WHEN IT WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776366 ↗
• InjuryMar 11, 2022Break; Break

  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 A LEAD BREAKAGE. THE LEAD FRAYED AND NOT ATTACHED TO BATTERY. IT WAS EXPLANTED AND ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13738833 ↗
• InjurySep 8, 2020Peeled/Delaminated; Peeled/Delaminated

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE OF HOW THE INSULATED COATING CAME APART WAS UNKNOWN, BUT THEY DID KNOW IT HAPPENED WHEN THE BOOT WAS PRESSED OVER THE CONNECTION PIECE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10502789 ↗
• MalfunctionJul 1, 2020Break; Difficult to Insert; Material Twisted/Bent; Break; Difficult to Insert; Material Twisted/Bent

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT IT WAS REPORTED THAT THE INITIAL LEAD HAD NEVER BEEN TUNNELED TO BEGIN WITH. THE SURGERY PROCEDURE TOOK LONGER THAN EXPECTED AS A RESULT OF THE ISSUE. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10219098 ↗
• MalfunctionJun 17, 2020Break; Peeled/Delaminated; Human-Device Interface Problem; Break; Peeled/Delaminated; Human-Device Interface Problem

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) APPLIED TO MUCH PRESSURE TO THE LEAD WHEN PUTTING ON THE BOOT DURING THE STAGE 1 PROTOCOL AND THE INSULATION RIPPED OFF OF THE LEAD. THE LEAD WAS REPLACED. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10162550 ↗
• MalfunctionJun 12, 2020Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP STATED THAT THERE WAS NO DEVICE ISSUE AND NO PATIENT/PROCEDURE ISSUE. THE REP STATED THAT WHEN CHECKED POST-OPERATIVELY, THE IMPEDANCE ISSUE WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10149080 ↗
• MalfunctionJun 2, 2020Break; Positioning Problem; Break; Positioning Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REP REPORTED THAT THE IMPLANTING PHYSICIAN NOTED RESISTANCE WHEN THE LEAD WAS ADVANCED THROUGH THE LEAD INTRODUCER SHEATH. THE RESISTANCE WAS NOTED WHEN THE FIRST DEPTH MARKER OF THE LEAD PASSED THROUGH THE TOP OF THE INTRODUCER SHEATH, HOWEVER THEY WERE UNABLE TO ADVANCE THE LEAD ANY FURTHER. THE LEAD WAS REMOVED FROM THE INTRODUCER SHEATH AND IT WAS NOTED THAT THE LEAD HAD BROKEN BETWEEN THE TINES. THERE WERE NO CONTRIBUTING FACTORS REPORTED. THE BROKEN LEAD WAS REMOVED FROM THE STERILE FIELD AND A NEW LEAD WAS OPENED TO FIELD AND IMPLANTED WITHOUT AN ISSUE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10109172 ↗
• MalfunctionMay 19, 2020Break; Peeled/Delaminated; Break; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL VIA A MANUFACTURE REPRESENTATIVE REGARDING A PATIENT WHO WAS USING WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PUTTER SHEATH IN THE LEAD WAS PULLED AWAY A SMALL DISTANCE AT THE END THAT GOES INTO THE INS. IT WAS FOUND WHEN MOVING FROM STAGE 1 TO STAGE 2. ONCE THE LEAD WAS PLACED INTO THE INS WITH THE SET SCREW THE ENTIRE PORTION WAS COVERED AND HAD PERFECT IMPEDANCE. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. 2020-MAY-19 E1 (REP): NO NEW INFO FOR EVENT DESCRIPTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10070679 ↗
• MalfunctionMay 8, 2020Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT UNDERGOING AN IMPLANT FOR NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THE REP WAS AT A CASE TODAY AND THE LEAD KIT WAS MISSING A TUNNELING TOOL WEDGE TIP, SO THE PHYSICIAN USED ANOTHER LEAD KIT. NO SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10038728 ↗
• MalfunctionMar 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  NO NEW INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9860231 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL. IT WAS REPORTED THAT THE PATIENT¿S ALLERGIC REACTION DID RESOLVE. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Swelling

  MAUDE report 9844924 ↗
• MalfunctionMar 17, 2020Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT DURING AN LEAD PLACEMENT FOR TRIAL, THE HEALTHCARE PROVIDE ATTEMPTED TO SLIDE BOOT OVER THE CONNECTED PERCUTANEOUS EXTENSION, AND LEAD WAS SEPARATED FROM THE ELECTRODES EXPOSING THE INSULATED PORTION OF THE LEAD. THE DAMAGED LEAD WAS REMOVED AND REPLACED. THE DAMAGED LEAD WAS DISCONNECTED AND REMOVED AND ENTIRE LEAD WAS REPLACED. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9844591 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA THE MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THERE WAS AN INFECTION FOUND AT THE POCKET SITE WHEN THE STAGE 1 EVALUATION WAS FINISHED. THE PHYSICIAN CLEANED THE POCKET, IRRIGATED POCKET WITH ANTIBIOTICS AND PROCEEDED WITH STAGE 2 IMPLANT AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: Unspecified Infection

  MAUDE report 9735071 ↗
• InjuryFeb 20, 2020Break; Break

  NO NEW INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9733495 ↗
• InjuryJan 31, 2020Break; Peeled/Delaminated; Break; Peeled/Delaminated

  THE REP REPORTED INFORMATION IDENTIFYING THE PATIENT AND DID NOT KNOW THE WEIGHT OF THE PATIENT. INFORMATION WAS ALSO REPORTED IN MANUFACTURER REPORT NUMBER 3007566237-2020-00169 AND WAS DIRECTED TO FOLLOW UP HERE GOING FORWARD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9653326 ↗
• InjuryJan 27, 2020Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING A LEAD. REP REPORTED A LEAD BREAK DURING THE PROCEDURE; NO FAULT WAS BLAMED ON THE HCP. THEY NOTED THAT THE PLASTIC WAS PULLED BACK FORM THE WIRE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE ARE KNOWN. THE ACTION/INTERVENTION TAKEN TO RESOLVE THE ISSUE WAS THE BROKEN LEAD WAS SURGICALLY REMOVED AND AN INTACT ONE WAS IMPLANTED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9633067 ↗
• MalfunctionJan 27, 2020Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP), VIA THE MANUFACTURER¿S REPRESENTATIVE, REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE COATING OF THE LEAD CAME BACK, WHICH EXPOSED THE COILED WIRES. AS AN FACTOR THAT MAY HAVE LED TO THE ISSUE, THE PHYSICIAN REMOVED AND REPOSITIONED THE LEAD SEVERAL TIMES TRYING TO FIND OPTIMAL PLACEMENT. NO TROUBLESHOOTING WAS PERFORMED. THE LEAD WAS THEN REMOVED AND REPLACED. NO SURGICAL INTERVENTION HAD OCCURRED AND NONE WERE PLANNED. THE ISSUE WAS REPORTED AS RESOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9632948 ↗
• InjuryJan 23, 2020Break; Break

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) VIA A HEALTHCARE PROVIDER (HCP) REGARDING A LEAD. A REP REPORTED A LEAD BREAK UPON REMOVAL. THEY NOTED THAT THEY WEREN'T PRESENT IN THE CASE AND WAS INFORMED THAT THE HCP WASN'T PUTTING A LOT OF TENSION ON THE LEAD WHILE REMOVING IT, BUT IT SEPARATED. THE INTERVENTIONS/ACTIONS TAKEN TO RESOLVE THE ISSUE INCLUDED ASKING THE HCP TO SAVE THE LEAD FOR THE REP SO IT COULD BE RETURNED FOR ANALYSIS. THE HCP ALSO NOTED THAT THEY HAD TO DISSECT DOWN IN ORDER TO REMOVE THE REMAINING PORTION. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9622348 ↗
• InjuryJan 21, 2020Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS CONFIRMED THAT THE OUTER INSULATION SEPARATED AT THE BUTT JOINT OF THE PROXIMAL END. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9613024 ↗
• MalfunctionJan 10, 2020Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR AN UNKNOWN PELVIC HEALTH THERAPY. IT WAS REPORTED THAT THE LEAD BROKE AT THE FORAMEN DURING EXPLANT AND ALL 4 ELECTRODES REMAIN IN S3. THE HCP TRIED TO EXPOSE TIMES AND WAS UNABLE TO VISUALIZE DUE TO THE SIZE OF THE PATIENT. UTILIZED FLUOROSCOPY TO IDENTIFY LOCATION OF ELECTRODES. A NEW LEAD WAS PLACED IN THE FORAMEN AND MOTOR RESPONSE WAS ACHIEVED ON ALL FOUR CONTACTS UNDER 1.0MA. NO FURTHER DEVICE ISSUE ALLEGED/IDENTIFIED. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9577503 ↗
• InjuryJan 8, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD WAS READY TO BE CONNECTED TO THE INS DURING A REVISION/ REPLACEMENT. THE SHEATH OF THE LEAD WAS FOUND TO BE LOOSE, EXPOSING THE BRAIDED WIRES NEAR THE ELECTRODES/ BELOW THE BLUE ELECTRODE. THE LEAD WAS REMOVED WITHOUT DIFFICULTY AND A NEW LEAD WAS PLACED. THERE WERE NO KNOWN CONTRIBUTING FACTORS. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9564291 ↗
• InjuryJan 7, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEAD APPEARED TO NOT LOOK RIGHT ACCORDING TO THE PHYSICIAN, BUT IT WAS TUNNELED TO THE POCKET ANYWAY. AFTER RETRIEVING THE LEAD FROM THE TUNNELING TOOL SHEATH, THE ELECTRODES APPEARED TO BE PULLING APART FROM THE LEAD WIRE. THE LEAD WAS REMOVED AND A NEW LEAD WAS PLACED WITH NO ISSUES. THE PATIENT WAS UNHARMED. THERE WERE NO KNOWN CONTRIBUTING FACTORS. IT WAS REPORTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9557291 ↗
• MalfunctionDec 19, 2019Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR AND URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE LEAD WAS DEFECTIVE AND WAS NEVER USED ON THE PATIENT. WHEN THE SCRUB TECHNICIAN OPENED THE LEAD AND HANDED IT TO THE PHYSICIAN. THE PHYSICIAN NOTICED THAT THE PLASTIC CASING BETWEEN THE TINES AND THE ELECTRODES WERE NOT ATTACHED LEAVING RAW WIRES EXPOSED BETWEEN THE TINES AND ELECTRODES. THE NURSE OPENED A NEW LEAD WITH THE SAME LOT NUMBER AND THERE WAS NO DEFECT OBSERVED. THE NEW LEAD WAS USED FOR THE PROCEDURE AND THE DEFECTIVE LEAD WAS PLACED IN A BIOHAZARD BAD AND WAS GIVEN TO THE MANUFACTURER REPRESENTATIVE. THE PATIENT IS ALIVE AND NO INJURY WAS REPORTED AT THE TIME OF THIS REPORT. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9495920 ↗
• MalfunctionDec 19, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated

  INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REPRESENTATIVE STATED THAT LEAD SHEATH SHEARED AT THE DISTAL CONNECTION POINT WITH THE ELECTRODE WHEN CONNECTING IT TO THE PERCUTANEOUS EXTENSION AND SLIDING THE BOOT OVER THE WIRE. THE PRODUCT WAS NEVER IMPLANTED. NO PATIENT ISSUES, STRICTLY DEVICE. LEAD WAS REMOVED AND REPLACED WITH ANOTHER PRODUCT. NO TROUBLESHOOTING POSSIBLE. NO EXTERNAL FACTORS, NORMAL PROCEDURAL STEPS FOLLOWED. THERE WERE NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9492275 ↗

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