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Axonics 1501Recalls & reported problems

Axonics Modulation Technologies, Inc. · Clinician Programmer · Class 3

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10810005340028), received between Feb 5, 2020 and Feb 5, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (1 report).

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

Device problems

  • Disconnection1
  • Impedance Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 5, 2020Disconnection; Impedance Problem

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

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9671707 ↗

Other Stimulator, Electrical, Implantable, For Incontinence devices

All Stimulator, Electrical, Implantable, For Incontinence devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.