Irhythm Technologies, Inc
FDA adverse event reports naming Irhythm Technologies, Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: IRHYTHM TECHNOLOGIES, INC.
- Total reports
- 1,529
- Deaths
- 26
- Injuries
- 840
- Malfunctions
- 663
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2022-11-04Open, ClassifiedDevice Design
Zio AT Clinical Reference Manual, Part: ALB0031, and Zio AT Important Information Pamphlet, Part: ALB0034. For Zio Ambulatory ECG monitoring system
Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached for either type, any further transmissions for that type will cease. Risk of delayed reporting to health providers.
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