Boston Scientific Corporation
FDA adverse event reports naming Boston Scientific Corporation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BOSTON SCIENTIFIC CORPORATION.
- Total reports
- 410,922
- Deaths
- 4,666
- Injuries
- 220,725
- Malfunctions
- 185,429
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Implantable Cardioverter Defibrillator (Non-Crt)LWS69,447
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP62,422
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN35,914
- Device, Impotence, Mechanical/HydraulicFHW16,615
- Coronary Drug-Eluting StentNIQ16,583
- Device, Incontinence, Mechanical/HydraulicEZY15,278
- Permanent Defibrillator ElectrodesNVY14,812
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK13,253
- System, Appendage Closure, Left AtrialNGV11,867
- Permanent Pacemaker ElectrodeDTB11,465
Recent recalls
- 2026-07-10Open, ClassifiedUnder Investigation by firm
Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Pro Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
- 2026-07-01Open, ClassifiedPackage design/selection
CRE Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
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