Axonics Modulation Technologies, Inc.
FDA adverse event reports naming Axonics Modulation Technologies, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: AXONICS MODULATION TECHNOLOGIES, INC..
- Total reports
- 1,487
- Deaths
- 2
- Injuries
- 1,368
- Malfunctions
- 117
Reports per year
Source: FDA adverse event reports by year received, 2020–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- TerminatedMaterial/Component Contamination
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
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