Haemonetics Corp.
FDA adverse event reports naming Haemonetics Corp. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: HAEMONETICS CORP..
- Total reports
- 1,237
- Deaths
- 18
- Injuries
- 41
- Malfunctions
- 1,165
Reports per year
Source: FDA adverse event reports by year received, 2000–2016. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Apparatus, AutotransfusionCAC1,103
- Separator, Automated, Blood Cell, DiagnosticGKT73
- Single (Specified) Analyte Controls (Assayed And Unassayed)JJX32
- Separator, Automated, Blood Cell And Plasma, TherapeuticLKN15
- Microfilter, Blood TransfusionCAK2
- Needle, Hypodermic, Single LumenFMI2
- System, Nuclear Magnetic Resonance ImagingLNH2
- System, Detection, Bacterial, For Platelet Transfusion ProductsMZC2
- Pump, Portable, Aspiration (Manual Or Powered)BTA1
- Reservoir, Blood, Cardiopulmonary BypassDTN1
Recent recalls
- 2011-07-06TerminatedOther
TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thrombelastograph Coagulation Analyzer TEG 5000 Series Used as the operational check and calibration verification for the TEG 5000 Thrombelastograph Hemostasis Analyzer System
Haemoscope received a report that during the process of Validation, Level II QC was running with an out-of-range low MA (Maximum Amplitude).
- 2011-03-21TerminatedOther
TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro coagulation studies; Haemonetics, Haemoscope Division, Niles, IL 60714; list number 07-022 a multipurpose system for in vitro coagulation studies
Haemonetics has received a report of smoke from the unit with a power supply failure.
Monitor Haemonetics Corp. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.