Cochlear Ltd
FDA adverse event reports naming Cochlear Ltd as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: COCHLEAR LTD.
- Total reports
- 18,201
- Deaths
- 12
- Injuries
- 15,260
- Malfunctions
- 2,921
Reports per year
45312
49113
9714
24015
40916
1,37917
1,42918
1,68419
1,97420
1,53121
1,23922
1,41423
1,90624
1,93225
1,19126
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implant, CochlearMCM16,197
- Active Implantable Bone Conduction Hearing SystemPFO1,729
- Cochlear Implant With Combined Electrical Stimulation And Acoustic AmplificationPGQ188
- Implant, Auditory BrainstemMHE57
- Hearing Aid, Bone Conduction, ImplantedMAH13
- Hearing Aid, Bone ConductionLXB12
- Prosthesis, Nose, InternalFZE3
- Barrier, Absorbable, AdhesionMCN1
- Inhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)PCQ1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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