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
- 7,474
- Deaths
- 3
- Injuries
- 6,269
- Malfunctions
- 1,202
Reports per year
112
413
114
315
716
1817
2018
5119
9720
87121
1,34322
1,34423
1,39224
1,62425
69826
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Implant, CochlearMCM6,248
- Active Implantable Bone Conduction Hearing SystemPFO1,163
- Cochlear Implant With Combined Electrical Stimulation And Acoustic AmplificationPGQ39
- Implant, Auditory BrainstemMHE18
- Hearing Aid, Bone ConductionLXB2
- Hearing Aid, Bone Conduction, ImplantedMAH2
- Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)PCQ2
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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