Boston Scientific - Fremont (sud)
FDA adverse event reports naming Boston Scientific - Fremont (sud) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BOSTON SCIENTIFIC - FREMONT (SUD).
- Total reports
- 1,976
- Deaths
- 3
- Injuries
- 136
- Malfunctions
- 1,837
Reports per year
2312
58813
68514
39615
13916
10117
4418
Source: FDA adverse event reports by year received, 2012–2018. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Imaging, Pulsed Echo, UltrasonicIYO893
- Catheter, Ultrasound, IntravascularOBJ526
- Catheter, Intravascular, DiagnosticDQO505
- Transducer, Ultrasonic, DiagnosticITX44
- Catheter, Coronary, AtherectomyMCX3
- Intracranial Neurovascular StentNJE3
- Coronary Drug-Eluting StentNIQ1
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD1
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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