Biosense Webster, Inc. (juarez)
FDA adverse event reports naming Biosense Webster, Inc. (juarez) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOSENSE WEBSTER, INC. (JUAREZ).
- Total reports
- 4,437
- Deaths
- 163
- Injuries
- 2,651
- Malfunctions
- 1,618
Reports per year
1007
5108
5609
9010
13811
38912
46913
64314
97315
92316
69517
Source: FDA adverse event reports by year received, 2007–2017. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Cardiac Ablation Percutaneous CatheterLPB2,828
- Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF722
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD676
- Catheter, Intracardiac Mapping, High-Density ArrayMTD91
- Introducer, CatheterDYB82
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE24
- Electrode, Pacemaker, TemporaryLDF7
- Computer, Diagnostic, ProgrammableDQK4
- Product code ------1
- Pack, Hot Or Cold, Water CirculatingILO1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor Biosense Webster, Inc. (juarez) 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.