Animas LLC
FDA adverse event reports naming Animas LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ANIMAS LLC.
- Total reports
- 16,695
- Deaths
- 5
- Injuries
- 549
- Malfunctions
- 16,141
Reports per year
10,53818
5,93219
22520
Source: FDA adverse event reports by year received, 2018–2020. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Pump, Infusion, Insulin, To Be Used With Invasive Glucose SensorOYC13,751
- Pump, Infusion, InsulinLZG2,922
- Sensor, Glucose, InvasiveMDS17
- Set, Administration, IntravascularFPA1
- Pump, InfusionFRN1
- Endoscopic Guidewire, Gastroenterology-UrologyOCY1
- Patient Bed With Canopy/RestraintsOYS1
- Post Breast Biopsy Hemostatic Breast Compression DevicePOY1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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