Boston Scientific - Fremont (ce)
FDA adverse event reports naming Boston Scientific - Fremont (ce) as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BOSTON SCIENTIFIC - FREMONT (CE).
- Total reports
- 1,378
- Deaths
- 11
- Injuries
- 60
- Malfunctions
- 1,307
Reports per year
3412
31313
25214
24515
21116
21117
11218
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
- Catheter, Ultrasound, IntravascularOBJ829
- Catheter, Coronary, AtherectomyMCX282
- System, Imaging, Pulsed Echo, UltrasonicIYO117
- Device, Thermal Ablation, EndometrialMNB49
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI40
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FlutterOAD27
- Catheter, Intravascular, DiagnosticDQO16
- Catheter, Peripheral, AtherectomyMCW7
- Amplifier And Signal Conditioner, Transducer SignalDRQ4
- Computer, Diagnostic, ProgrammableDQK2
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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