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
- 29,691
- Deaths
- 1,655
- Injuries
- 10,827
- Malfunctions
- 16,891
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
- 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
- 2026-08-20Open, 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.
- 2026-08-05Open, ClassifiedDevice Design
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
- 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.
Monitor Boston Scientific automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.