Cochlear Limited
FDA adverse event reports naming Cochlear Limited as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COCHLEAR LIMITED.
- Total reports
- 7,417
- Deaths
- 3
- Injuries
- 6,220
- Malfunctions
- 1,194
Reports per year
111
413
114
315
716
1817
2018
5119
9720
87121
1,34322
1,34323
1,39124
1,62625
64026
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implant, CochlearMCM6,203
- Active Implantable Bone Conduction Hearing SystemPFO1,154
- Cochlear Implant With Combined Electrical Stimulation And Acoustic AmplificationPGQ39
- Implant, Auditory BrainstemMHE16
- Hearing Aid, Bone ConductionLXB2
- Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)PCQ2
- Hearing Aid, Bone Conduction, ImplantedMAH1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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