Axonics 1801Recalls & reported problems
Axonics Modulation Technologies, Inc. · Lead Implant Kit · Class 3
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10810005340080), received between Aug 11, 2023 and Mar 19, 2026 — classified as 6 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Break” (15 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.
Reports received per month
Most reported problems
Device problems
- Break15
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
- Material Integrity Problem1
- Material Split, Cut or Torn1
Patient problems
- Failure of Implant9
- Incontinence6
- Foreign Body In Patient2
- Cough1
- Vomiting1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2026Fracture; Material Integrity Problem
IT WAS REPORTED THAT THE PHYSICIAN HAD THE SHEATH IN THE FORAMEN, BUT WAS NOT RECEIVING THE DESIRED RESULTS WHEN THE LEAD WAS INTRODUCED, SO IT WAS DISCUSSED TO TRY A NEW NEEDLE PLACEMENT. THE PHYSICIAN SAID TO TAKE THE SHEATH OUT, BUT WANTED TO KEEP IT AS A BACKUP. THE PHYSICIAN PROCEEDED TO PUT A NEW NEEDLE IN THE SAME FORAMEN AS THE SHEATH. ONCE THE DESIRED RESULTS WERE ACHIEVED WITH THAT NEEDLE, THE PHYSICIAN THEN PULLED OUT THE SHEATH. IN DOING SO, THEY REALIZED THAT THE NEEDLE HAD PUNCTURED THE EXISTING SHEATH IN THE FORAMEN AND HAD TRAPPED PART OF THE SHEATH UNDER THE NEEDLE. THEY REMOVED THE NEEDLE TO SEE IF THEY COULD RETRIEVE THE SHEATH SEGMENT CONTAINING THE RADIOPAQUE MARKER. THE PHYSICIAN TRIED TO RETRIEVE THE SHEATH BUT WAS UNSUCCESSFUL. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: Foreign Body In Patient
MAUDE report 24641791 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING STAGE 1 OF THE PATIENT'S ADVANCED TRIAL, THE PROCEDURE WAS ABORTED AFTER THE PATIENT WAS GIVEN ANESTHESIA WITHOUT INTUBATION. THE NEEDLE WAS PLACED IN THE FORAMEN AND ALTHOUGH THE PROCEDURE PROGRESSED NORMALLY, PRIOR TO THE LEAD BEING PLACED, THE PATIENT BEGAN COUGHING AND VOMITING BILE INTO THE OXYGEN FACE MASK. IT WAS DETERMINED THAT THE PATIENT NEEDED TO BE FLIPPED SUPINE TO CLEAR AND MAINTAIN AIRWAY. THE PRODUCTS USED FOR THE LEAD PLACEMENT WERE REMOVED, AND THE PROCEDURE WAS CANCELLED. THERE WERE NO DEVICE ISSUES.
Patient problems: Cough; Vomiting
MAUDE report 24608346 ↗MalfunctionMay 15, 2025Break; Break
THE LEAD INTRODUCER BROKE OFF INSIDE THE PATIENT.
Patient problems: Incontinence
MAUDE report 22028412 ↗MalfunctionNov 7, 2024Break; Break
THE LEAD INTRODUCER BROKE OFF INSIDE THE PATIENT.
Patient problems: Incontinence
MAUDE report 20635138 ↗MalfunctionSep 26, 2024Break; Break
THE LEAD INTRODUCER BROKE OFF INSIDE THE PATIENT.
Patient problems: Incontinence
MAUDE report 20315905 ↗InjuryJul 3, 2024Break; Break
THE INTRODUCER SHEATH BROKE OFF INSIDE THE PATIENT.
Patient problems: Incontinence
MAUDE report 19669302 ↗MalfunctionJun 21, 2024Break; Break
THE INTRODUCER SHEATH BROKE OFF INSIDE THE PATIENT.
Patient problems: Incontinence
MAUDE report 19585172 ↗MalfunctionJun 17, 2024Break; Break
THE LEAD INTRODUCER BROKE OFF INSIDE THE PATIENT.
Patient problems: Incontinence
MAUDE report 19554571 ↗MalfunctionJan 15, 2024Break; Break
THE GUIDEWIRE BROKE REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 18514874 ↗MalfunctionDec 4, 2023Break; Break
THE BI-DIRECTIONAL GUIDE BROKE REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 18257245 ↗MalfunctionNov 17, 2023Break; Break
THE DIRECTIONAL GUIDE BROKE OFF IN THE PATIENT REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 18162121 ↗MalfunctionNov 17, 2023Break; Break
THE DIRECTIONAL GUIDE BROKE REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 18162088 ↗MalfunctionNov 6, 2023Break; Break
THE DIRECTIONAL GUIDE BROKE REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 18080428 ↗InjuryOct 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
THE COMPANY WAS MADE AWARE THAT AN INTRODUCER SHEATH BECAME FRAYED INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17896406 ↗MalfunctionSep 20, 2023Break; Break
THE BI-DIRECTIONAL GUIDE BROKE INSIDE A PATIENT.
Patient problems: Failure of Implant
MAUDE report 17785224 ↗MalfunctionSep 14, 2023Break; Break
THE BI-DIRECTIONAL GUIDE BROKE REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 17749691 ↗InjuryAug 29, 2023Break; Break
THE BI-DIRECTIONAL GUIDE BROKE REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 17643405 ↗InjuryAug 11, 2023Break; Break
THE BI-DIRECTIONAL GUIDE BROKE REQUIRING SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 17515624 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.