Boston Scientific
FDA adverse event reports naming Boston Scientific as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BOSTON SCIENTIFIC.
- Total reports
- 29,689
- Deaths
- 1,655
- Injuries
- 10,827
- Malfunctions
- 16,889
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
- Coronary Drug-Eluting StentNIQ10,673
- Catheters, Transluminal Coronary Angioplasty, PercutaneousLOX4,400
- Stent, CoronaryMAF2,159
- Wire, Guide, CatheterDQX1,777
- Stents, Drains And Dilators For The Biliary DuctsFGE1,215
- Catheter, Angioplasty, Peripheral, TransluminalLIT767
- Catheter, Coronary, AtherectomyMCX635
- Catheter, PercutaneousDQY597
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysLJS390
- Port & Catheter, Implanted, Subcutaneous, IntravascularLJT388
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.
- 2026-07-08Open, ClassifiedPackaging process control
Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU
Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.
- 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.
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