Axonics 1601Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10810005340059), received between Feb 12, 2020 and Sep 10, 2025 — classified as 10 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High impedance” (3 reports).

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROUTINE CHECK-IN BY THE REPRESENTATIVE ON THE PATIENT, THE PATIENT MENTIONED THAT THEY HAD A URINARY TRACT INFECTION (UTI), DURING THE TRIAL STAGE ON (B)(6) 2025, WHICH POSSIBLY STARTED THE FIRST DAY OF THEIR TRIAL. THE PATIENT WAS GIVEN ANTIBIOTICS (NITROFURANTOIN) THAT TREATED THE INFECTION. THE CAUSE OF THE UTI MAY HAVE BEEN FROM THE CATHETER. THE PATIENT IS NOT SCHEDULED FOR ANY FOLLOW-UP APPOINTMENTS WITH THEIR UROLOGIST. THE PATIENT DOES NOT HAVE A CURRENT UTI. THE LOCAL FIELD TEAM AND HEALTH CARE FACILITY WERE AWARE OF THE PATIENT'S UTI DURING THE TIME THE PATIENT WENT THROUGH THEIR TRIAL ON (B)(6) 2025. NOW THE PATIENT IS FULLY RECOVERED FROM THE UTI. THERE ARE NO OTHER PATIENT COMPLICATIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 23019557 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. THE REPRESENTATIVE REPORTED THAT THE PATIENT IS DOING WELL. THE BASIC TRIAL WAS SUCCESSFUL FOR THE PATIENT. THE INFECTION WAS A URINARY TRACT INFECTION (UTI) THAT THE PATIENT HAD, WHICH STARTED APPROXIMATELY A WEEK AFTER THE BASIC TRIAL PROCEDURE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR THE UTI. THE SPECIMEN WAS SENT OUT FOR A URINE CULTURE, BACTERIAL UTI. THE PATIENT HAS DIABETES AND WAS ON JARDIANCE, WHICH IS KNOWN TO CAUSE UTIS, PER THE PATIENT. THE PATIENT STOPPED GETTING UTIS WHEN SHE WENT OFF THE MEDICATION.

  Patient problems: Urinary Tract Infection

  MAUDE report 22820142 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT EXPERIENCED PAIN AT THE TRIAL PROCEDURE SITE. THEY PATIENT RECEIVED OXYCODONE, PLEXERIL, AND MOBIC. THE INVESTIGATOR REPORTED THIS ADVERSE EVENT WAS PROCEDURE RELATED. IT WAS LATER REPORTED THAT NO FURTHER INFORMATION WAS AVAILABLE, INCLUDING THE OUTCOME OF THE INCIDENT. THE PARTICIPANT EXITED THE CLINICAL STUDY IMMEDIATELY AFTER THE TRIAL PROCEDURE.

  Patient problems: Implant Pain

  MAUDE report 22668620 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME BACK PAIN AND STIFFNESS DURING AND AFTER THE TRIAL. THEY BELIEVE THAT THERE WAS A GLITCH BETWEEN THE CLINICIAN PROGRAMMER AND THE REMOTE CONTROL THAT CAUSED HER TO RECEIVE OVERSTIMULATION. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE AN MRI WAS PERFORMED TO CONFIRM A HEMATOMA. THE DEVICE WAS REMOVED BUT THE PATIENT IS STILL EXPERIENCING BACK PAIN AND STIFFNESS. THE PATIENT WAS INSTRUCTED TO SEEK MEDICAL ATTENTION. IT WAS LATER REPORTED THAT THE PATIENT IS STILL IN PAIN. THEY WERE ADVISED TO CONTACT THE TREATING PHYSICIAN. THE PATIENT WANTS TO UNDERSTAND THE EFFECTS OF OVERSTIMULATION OVER A 48 HOUR PERIOD. THE PATIENT FEELS THERE WAS A GLITCH WITH THE CP AND THE REMOTE. THEY ALSO NOTED THE STIMULATION HAD BEEN LEFT AT A HIGH SETTING, WITH SENSATION EXPERIENCED ONLY IN THE BACK. PATIENT WAS ADVISED REPEATEDLY TO CONTACT THEIR PHYSICIAN FOR ANY MEDICAL CONCERNS. IT WAS REPORTED TWO DAYS LATER THAT PATIENT IS STILL EXPERIENCING SEVERE RIGHT LEG AND BUTTOCK PAIN, BACK STIFFNESS, MOBILITY ISSUES, AND SPASMS CAUSING UNCONTROLLED URINATION DESPITE THE USE OF MUSCLE RELAXERS. THE PATIENT BELIEVES THE TRIAL MAY HAVE CAUSED NERVE DAMAGE. T

  Patient problems: Cramp(s) /Muscle Spasm(s); Device Overstimulation of Tissue; Hematoma; Pain; Unspecified Musculoskeletal problem; Urinary Incontinence

  MAUDE report 22376514 ↗
• InjuryJun 25, 2025Lack of Effect; Lack of Effect

  IT WAS REPORTED THAT A PATIENT HAD A PNE TRIAL AND WAS IN EXTREME PAIN FOLLOWING THE PROCEDURE AND UNABLE TO COMMUNICATE. AT THE TIME OF PROGRAMMING THE EPG, THE PATIENT WAS UNABLE TO FEEL ANYTHING. THE PATIENT WAS GIVEN A LARGE DOSE OF PAIN MEDICATION MAKING IT DIFFICULT TO COMMUNICATE. THE NEXT DAY THE PATIENT STATED MULTIPLE TIMES THAT SHE DIDN'T FEEL ANYTHING BUT MENTIONED SHE WAS HAVING MUSCLE SPASMS. THE STIMULATION WAS THEN TURNED DOWN AND THAT HELPED THE PATIENT TO NOT BE IN DISCOMFORT AT THAT TIME. A FEW DAYS FOLLOWING, THE PATIENT WAS STILL IN DISCOMFORT AND THE COMPANY REPRESENTATIVE HAD TO TURN OFF HER STIMULATION COMPLETELY. THE PATIENT STATED SHE WAS GOING TO THE ER BECAUSE HER ENTIRE BODY WAS SORE. REPROGRAMMING WAS ATTEMPTED AGAIN WITH THE ON-CALL UROLOGIST AT THE ER VISIT AND THE PATIENT WAS STILL IN PAIN. THE DEVICE WAS TURNED OFF AGAIN AND ADVISED TO SEE HER IMPLANTING PHYSICIAN FOR A LEAD PULL.

  Patient problems: Pain; Undesired Nerve Stimulation

  MAUDE report 22331314 ↗
• InjuryJun 13, 2025Defective Device; Communication or Transmission Problem; Defective Device; Communication or Transmission Problem

  IT WAS REPORTED THAT AFTER THE PATIENT HAD A 3RD SPACING OF FLUID, THE PATIENT'S FLUID WAS OVERLOADED AND NEEDED A PARACENTESIS. THE PATIENT HAD A PARACENTESIS AND THEN WENT INTO THE CLINIC TO HAVE THEIR EXTERNAL TRIAL STIMULATOR (ETS) REPLACED. THE PATIENT HAD FLUID DRAINING FROM THEIR PERC EXTENSION SITE AND THE INCISION SITE, WHICH CAUSED THE ETS TO NO LONGER WORK. THE REMOTE WAS UNABLE TO BE CONNECTED AS WELL SO THE REMOTE WAS ATTEMPTED TO BE RESET. THE CLINIC BANDAGED THE DRESSING SO THAT THE ETS WAS NOT VISIBLE, AND THEREFORE, IT WAS UNKNOWN IF A RED LIGHT WAS SEEN. THE PATIENT WAS SCHEDULED FOR TROUBLESHOOTING THE DAY AFTER THEIR PARACENTESIS. THEN, THE ETS WAS REPLACED AND WRAPPED WITH TEGADERM TO PREVENT ANY FURTHER EVENTS OF THE ETS GETTING WET. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205711 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRESCRIBED MEDICATION FOR PAIN.

  Patient problems: Incontinence; Pain

  MAUDE report 22010602 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS HOSPITALIZED DUE TO EXCESSIVE BLEEDING FROM BLOOD THINNERS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Incontinence

  MAUDE report 22010496 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS HOSPITALIZED DUE TO A HEMATOMA.

  Patient problems: Hematoma; Incontinence

  MAUDE report 21955228 ↗
• MalfunctionMay 24, 2024High impedance; High impedance

  THE PATIENT UNDERWENT REVISION SURGERY DUE TO HIGH IMPEDANCE.

  Patient problems: Failure of Implant; Incontinence

  MAUDE report 19397817 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A BLOOD TRANSFUSION AND EXPLANT SURGERY FOLLOWING THE PNE PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 18257234 ↗
• MalfunctionMar 2, 2023High impedance; High impedance

  THE COMPANY WAS MADE AWARE THAT A PHYSICIAN PERFORMED A REVISION SURGERY DUE TO HIGH IMPEDANCE.

  Patient problems: Failure of Implant

  MAUDE report 16465279 ↗
• MalfunctionJul 24, 2020Disconnection; Disconnection

  PATIENT'S EPG (TRIAL STIMULATOR) DISCONNECTED FROM THE PERCUTANEOUS EXTENSION (PE). THE REPRESENTATIVE MET WITH THE PATIENT AND OBSERVED THE PRONGS INSIDE THE EPG CONNECTOR WERE BENT. PER THE REPRESENTATIVE, THE EPG WAS PULLED FROM THE PE AND THE PRONGS INSIDE THE EPG WERE DAMAGED AS A RESULT. THE REPRESENTATIVE WAS UNABLE TO RECONNECT THE EPG TO THE PE. THE EPG WAS REPLACED AND PATIENT WAS REPROGRAMMED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10322220 ↗
• MalfunctionJul 2, 2020Disconnection; Disconnection

  AN ADVANCED TRIAL PATIENT HAD A SOLID RED LIGHT ON THEIR PATIENT REMOTE. THE REPRESENTATIVE HAD THE PATIENT SWITCH PROGRAMS, BUT THE SOLID RED LIGHT WAS STILL BEING DISPLAYED AND AS A RESULT, PATIENT WAS NOT RECEIVING ANY STIMULATION. THE REPRESENTATIVE MET WITH THE PATIENT AND OBSERVED THE EPG (TRIAL STIMULATOR) HAD BECOME DISCONNECTED FROM THE PERCUTANEOUS EXTENSION. THE CONNECTION WAS RESTORED AND THE ISSUE WAS RESOLVED.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10225064 ↗
• MalfunctionJun 22, 2020Failure to Conduct; Failure to Conduct

  ON (B)(6) 2020, PATIENT REPORTED SYMPTOMS RETURNING AND A BLINKING RED LIGHT ON THEIR EPG (TRIAL STIMULATOR). THE REPRESENTATIVE MET WITH THE PATIENT AND CONNECTED TO THE EPG WITH THE CLINICIAN PROGRAMMER (CP). AN ERROR MESSAGE DISPLAYED ON THE CP. THE ERROR MESSAGE APPEARS TO BE A RESULT OF A VOLTAGE/CURRENT FEEDBACK ERROR. THE REPRESENTATIVE REPLACED THE EPG TO RESTORE THERAPY.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 10180966 ↗
• MalfunctionApr 17, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES AND SECTION H, NUMBER 10, ADDITIONAL MANUFACTURER NARRATIVE.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9973090 ↗
• MalfunctionApr 8, 2020Failure to Interrogate; Failure to Interrogate

  ON (B)(6) 2020, PATIENT FELT A "POP" IN THEIR TAILBONE AREA AND REPORTED FEELING PAIN AFTER THE POP SENSATION. PRIOR TO THE TRIAL PERIOD, THE PATIENT HAD NEVER EXPERIENCED THAT SENSATION. THE PATIENT WAS IN THE STAGE 1 TRIAL AND DOING WELL. THE PAIN EVENTUALLY WENT AWAY. ON (B)(6) 2020, PATIENT REPORTED EXPERIENCING PAIN ACROSS THEIR LOW BACK WHILE DRIVING HOME FROM A DOCTOR APPOINTMENT UNRELATED TO THE DEVICE. PATIENT WAS UNABLE TO CORRELATE THE PAIN TO ANY OCCURRENCE. DURING THIS TIME, THE PATIENT REPORTED TO THE CLINICAL SPECIALIST (CS) THAT THEY WERE UNSURE WHEN THEY LAST FELT STIMULATION FROM THE DEVICE, BUT BELIEVED IT STOPPED AROUND THE SAME TIME AS THE ONSET OF THE LOW BACK PAIN. PATIENT WAS HAVING DIFFICULTY CONNECTING THEIR PATIENT REMOTE TO THE TRIAL STIMULATOR (EPG). ATTEMPTS WERE MADE TO RESOLVE THE ISSUE BY CHECKING ALL CONNECTIONS AND RESTARTING THE PATIENT REMOTE AND TRIAL STIMULATOR, BUT RESULTS REMAIN THE SAME. ON (B)(6) 2020, THE PATIENT MET WITH THE CS AND DOCTOR. THE DOCTOR OBSERVED THE PATIENT'S BACK AND NOTED THAT IT LOOKED NORMAL. THE CS CONNECTED TO THE TRIAL STIMULATOR USING THEIR CLINICIAN PROGRAMMER AND NOTICED AN ERROR MESSAGE HAD DISPLAYED STATING TO R

  Patient problems: Pain; Therapeutic Response, Decreased

  MAUDE report 9936326 ↗
• MalfunctionMar 6, 2020High impedance; High impedance

  SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9801207 ↗
• MalfunctionFeb 21, 2020Communication or Transmission Problem; Communication or Transmission Problem

  SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9740902 ↗
• MalfunctionFeb 12, 2020Failure to Conduct; Failure to Conduct

  SEE SECTION H, NUMBER 6, EVENT PROBLEM AND EVALUATION CODES.

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 9700633 ↗