Axonics 1901Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10810005340127), received between Feb 6, 2020 and May 26, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BASIC TRIAL. FOUR DAYS LATER, THE PATIENT FELL AT HOME AND WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH SEPSIS. THE PHYSICIAN DOES NOT SUSPECT THAT THE PATIENT'S INFECTION IS RELATED TO THE TRIAL STIMULATOR. THE DEVICE REMAINS IMPLANTED. THE PATIENT IS BEING TREATED FOR SEPSIS AND EXPECTED A FULL RECOVERY.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25283696 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT FELT LIKE THE STIMULATION MADE THEIR FREQUENCY WORSE. THE PATIENT ALSO MENTIONED DISCOMFORT FROM THE PNE LEAD PLACEMENT AND OPTED TO HAVE AN EARLY LEAD PULL.

  Patient problems: Discomfort; Urinary Frequency / Polyuria

  MAUDE report 24476584 ↗
• InjuryDec 19, 2025Fracture; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAD THEIR LEAD EXPLANTED DUE TO A FRACTURE AND PAIN DURING THEIR TRIAL. THE PATIENT EXPERIENCED THEIR BANDAGE COMING OFF AND HAD A RED LIGHT ON THEIR REMOTE CONTROL. TROUBLESHOOTING WAS ATTEMPTED AND IT WAS SUSPECTED THE CABLE DISCONNECTED. THE PHYSICIAN CHECKED UNDER THE BANDAGE AND DISCOVERED THE PNE WAS FRACTURED. THE PHYSICIAN ATTEMPTED TO REMOVE AND FIX THE LEAD AND DRESSINGS, BUT THE LEAD HAD ALREADY BROKEN OFF UNDER THE PATIENT'S SKIN. THEN THE PHYSICIAN EXPLANTED THE LEAD. THE PATIENT WAS SCHEDULED FOR ANOTHER STAGE 1 TRIAL, BUT THEY DECLINED TO MOVE FORWARD.

  Patient problems: Discomfort; Pain

  MAUDE report 23857572 ↗
• InjuryDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE INITIAL PNE LEAD PLACEMENT, ADEQUATE RESPONSES WERE NOT BEING PRODUCED, SO THE ORIGINAL LEAD WAS REMOVED, AND ANOTHER LEAD WAS PLACED. DURING THE REMOVAL OF THE FIRST LEAD, IT WAS NOTICED THAT THE TIP HAD BROKEN OFF AND WAS PRESUMABLY STILL IN THE PATIENT. AN X-RAY WOULD BE ORDERED TO ASSESS ONCE THE PNE TEST IS COMPLETED AND THE WIRES ARE REMOVED 2 WEEKS LATER. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED, AND NO FURTHER INFORMATION HAS BEEN OBTAINED TO DATE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783877 ↗
• InjuryOct 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT GOING THROUGH A TRIAL STAGE EXPERIENCED DISCOMFORT AND TENDERNESS AT THE SITE LOCATION WHERE THE LEAD EXITS THE SKIN. THE LEAD WAS PULLED OUT ON (B)(6) 2025, AND THE PATIENT WAS PRESCRIBED AUGMENTIN, WHICH ENDED ON (B)(6) 2025. THE PATIENT STATED THAT THE DISCOMFORT IN THEIR BUTTOCKS IS SLOWLY IMPROVING, BUT IT IS STILL TENDER WHEN SITTING. THE DISCOMFORT WAS DESCRIBED BY THE PATIENT AS MORE LIKE A BURN, BUT THERE'S A HARD CORE UNDER IT LIKE A HEMATOMA, WHICH IS SLOWLY DECREASING IN SIZE. THE OPENING WAS ABOUT THE SIZE OF A NICKEL. THE PATIENT THINKS THAT IT STARTED AS A BURN AND THEN PROGRESSED TO A WOUND. THE PATIENT WILL CONTINUE TO TAKE ANTIBIOTICS. THE REPRESENTATIVE ADVISED THAT THE PATIENT IS DOING MUCH BETTER. THE PATIENT WAS NOT PRESCRIBED ANY OTHER ANTIBIOTICS OR MEDICATIONS. THE DISCOMFORT AND PAIN HAVE GONE AWAY AND THE PATIENT HASN'T NOTICED IT FOR THE PAST FEW DAYS. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE PATIENT'S ISSUE, AND IF IT WAS AN INFECTION, THEY NEVER GOT A CLEAR DIAGNOSIS ON IT. THE PATIENT HAS A FOLLOW-UP APPOINTMENT WITH THE PHYSICIAN ON (B)(6) 2025, TO DISCUSS THE NEXT STEPS. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Burn(s); Discomfort; Hematoma; Pain; Skin Inflammation/ Irritation

  MAUDE report 23236957 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LEAD WAS FRAYED WHEN REMOVING IT FROM THE PATIENT. THE DOCTOR CUT THE LEAD, DISPOSED OF THE FRAYED PORTION, COVERED THE REMAINING LEAD, AND SENT THE PATIENT HOME ON ANTIBIOTICS. THE PHYSICIAN BELIEVES THE LEAD STARTED FRAYING UPON REMOVAL. THE PHYSICIAN WAS LATER ADVISED TO REMOVE IT IN AN OPERATING ROOM AS SOON AS POSSIBLE. THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2025. THE COMPLAINT WAS REPORTED IN ERROR. THE REPORTING PHYSICIAN IS A COLLEAGUE OF THE IMPLANTING PHYSICIAN AND COVERED THEIR DUTIES WHILE ON VACATION. THE LEAD WAS INCORRECTLY IDENTIFIED AS FRAYED. THE LEAD WAS PULLED OUT IN-CLINIC BY THE IMPLANTING PHYSICIAN. IT CAME OUT AS NORMAL, FULLY INTACT AND NOT FRAYED. THE PATIENT HAS TOLERATED EVERYTHING WELL AND WILL MOVE FORWARD WITH THE PERMANENT IMPLANT. THE PHYSICIAN REPORTED NO PRODUCT COMPLAINTS OR PROBLEMS AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22681302 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING LOWER BACK PAIN FROM THE PROCEDURE AND CHOSE TO HAVE THE LEADS REMOVED EARLY TO END THE BASIC TRIAL. THE PATIENT WAS UNABLE TO SIT OR LAY DOWN DUE TO SORENESS AND PAIN IN THE BACK SIDE. THE PHYSICIAN ATTRIBUTED THIS PAIN TO THE PROCEDURE. THERE WERE NO OTHER REPORTED COMPLICATIONS. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE CLINICAL SPECIALIST SENT IN AN UPDATE STATING THE PATIENT WAS STILL HAVING SOME SORENESS AFTER THE LEADS WERE PULLED, BUT NO OTHER COMPLICATIONS WERE LISTED.

  Patient problems: Pain

  MAUDE report 22441091 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AND ENDED THEIR BASIC TRIAL EARLY WITH A LEAD PULL. IT WAS NOTED THAT THE PATIENT WAS ALSO EXPERIENCING NON-DESIRED STIMULATION. THE PATIENT IS NOT CONSIDERING A NEW TRIAL IN THE FUTURE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

  Patient problems: Discomfort; Undesired Nerve Stimulation

  MAUDE report 22436729 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRESCRIBED ANTIBIOTICS DUE TO AN INFECTION.

  Patient problems: Incontinence; Unspecified Infection

  MAUDE report 21356299 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN EXPLANT SURGERY DUE TO A HEMATOMA.

  Patient problems: Hematoma; Incontinence

  MAUDE report 20251718 ↗
• InjuryAug 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A BLOOD TRANSFUSION DUE TO A SACRAL HEMATOMA.

  Patient problems: Hematoma; Incontinence

  MAUDE report 19992634 ↗
• MalfunctionMay 20, 2024Fracture; Fracture

  THE PATIENT UNDERWENT SURGERY TO RETRIEVE LEAD FRAGMENT.

  Patient problems: Foreign Body In Patient; Incontinence

  MAUDE report 19355105 ↗
• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS HOSPITALIZED FOR HEMATOMA.

  Patient problems: Hematoma; Incontinence

  MAUDE report 19336708 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS PRESCRIBED ANTIBIOTICS DUE TO AN UNSPECIFIC INFECTION AT THE LEAD SITE.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17410356 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE SECTION H, NUMBER 6, FOR AN INVESTIGATION UPDATE.

  Patient problems: Pain

  MAUDE report 17351545 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PNE LEAD EXPLANT DUE TO PAIN AND DEVELOPED A PRESACRAL ABSCESS.

  Patient problems: Abscess; Implant Pain

  MAUDE report 16523288 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS MADE AWARE ON (B)(6) 2020 THAT A PATIENT HAD DEVELOPED AN EDEMA AT THE PNE INSERTION SITE.

  Patient problems: Edema

  MAUDE report 10461356 ↗
• MalfunctionFeb 6, 2020Difficult to Remove; Stretched; Difficult to Remove; Stretched

  WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE FORAMEN NEEDLE OVER THE PNE LEAD, THE PNE LEAD BECAME STUCK IN THE NEEDLE AND THEN STRETCHED. THE PHYSICIAN THEN REMOVED THE ENTIRE LEAD.

  Patient problems: Failure of Implant

  MAUDE report 9677078 ↗