Medos International Sarl
FDA adverse event reports naming Medos International Sarl as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDOS INTERNATIONAL SARL.
- Total reports
- 13,641
- Deaths
- 92
- Injuries
- 1,819
- Malfunctions
- 11,729
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Intracranial Neurovascular StentNJE2,706
- Device, Vascular, For Promoting EmbolizationKRD2,652
- Fastener, Fixation, Nondegradable, Soft TissueMBI2,403
- ArthroscopeHRX1,405
- Device, Neurovascular EmbolizationHCG808
- Catheter, Percutaneous, NeurovasculatureQJP680
- Catheter, Continuous FlushKRA666
- Fastener, Fixation, Biodegradable, Soft TissueMAI484
- Orthopedic Manual Surgical InstrumentLXH376
- Accessories, Photographic, For Endoscope (Exclude Light Sources)FEM222
Recent recalls
- 2026-09-02Open, ClassifiedUnder Investigation by firm
Velys Enabling Tech Robotic-Assist Station REF: 451611001
Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
- 2024-03-13Open, ClassifiedUnder Investigation by firm
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
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