ICU Medical Healthcare Manufacturing S.A. DE C.V.
FDA adverse event reports naming ICU Medical Healthcare Manufacturing S.A. DE C.V. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V..
- Total reports
- 1,867
- Deaths
- 1
- Injuries
- 51
- Malfunctions
- 1,815
Reports per year
1024
42825
1,42926
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Set, Administration, IntravascularFPA1,301
- Set, I.V. Fluid TransferLHI214
- Tube, Tracheal (W/Wo Connector)BTR127
- Tube Tracheostomy And Tube CuffJOH69
- Tube, Tracheostomy (W/Wo Connector)BTO38
- Device, Warming. Blood And PlasmaKZL17
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT13
- Tubing, Fluid DeliveryFPK11
- Warmer, Thermal, Infusion FluidLGZ11
- Probe, Blood-Flow, ExtravascularDPT10
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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