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
- 417,411
- Deaths
- 4,745
- Injuries
- 223,455
- Malfunctions
- 189,109
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Implantable Cardioverter Defibrillator (Non-Crt)LWS70,441
- Implantable Pulse Generator, Pacemaker (Non-Crt)LWP64,010
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN36,525
- Device, Impotence, Mechanical/HydraulicFHW16,662
- Coronary Drug-Eluting StentNIQ16,657
- Device, Incontinence, Mechanical/HydraulicEZY15,440
- Permanent Defibrillator ElectrodesNVY15,143
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)NIK13,483
- System, Appendage Closure, Left AtrialNGV11,997
- Permanent Pacemaker ElectrodeDTB11,569
Recent recalls
- 2026-08-20Open, ClassifiedUnder Investigation by firm
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
- 2026-08-20Open, ClassifiedUnder Investigation by firm
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
- 2026-08-14Open, ClassifiedUnder Investigation by firm
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- 2026-08-14Open, ClassifiedUnder Investigation by firm
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
- 2026-07-31Open, ClassifiedProcess control
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radial Jaw 4 SC w/ Needle 240cm Box 20; Outer Box UPN: M00513411; Inner Box UPN: M00513410.
Potential for breach in sterile barrier of device packaging.
- 2026-07-31Open, ClassifiedProcess control
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.
Potential for breach in sterile barrier of device packaging.
- 2026-07-31Open, ClassifiedProcess control
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
Potential for breach in sterile barrier of device packaging.
- 2026-07-22Open, ClassifiedDevice Design
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
- 2026-07-20Open, ClassifiedUse error
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
- 2026-07-20Open, ClassifiedUse error
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
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