Biosense Webster, Inc (irwindale)
FDA adverse event reports naming Biosense Webster, Inc (irwindale) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOSENSE WEBSTER, INC (IRWINDALE).
- Total reports
- 1,322
- Deaths
- 100
- Injuries
- 907
- Malfunctions
- 314
Reports per year
408
909
4610
10711
17112
21913
49014
27615
Source: FDA adverse event reports by year received, 2008–2015. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Cardiac Ablation Percutaneous CatheterLPB625
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD344
- Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF230
- Introducer, CatheterDYB53
- Computer, Diagnostic, ProgrammableDQK30
- Catheter, Intracardiac Mapping, High-Density ArrayMTD20
- Catheter, Ultrasound, IntravascularOBJ20
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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