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All product recalls associated with Boston Scientific Corporation.
Total Recalls
1000
Past Year
566
Class I (Serious)
25
Most Recent
Jan 2026
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Tip detachment: Boston Scientific has received complaints involving a detachment of the tip from the NexStent Carotid Stent delivery system. Potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. Since the potential for the tip to detach occurs during delivery of the sten
Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.
An increase in complaints was noted for AxSYM Rubella IgG assay calibration failures due to error codes related to elevated Calibrator A (or Master Calibrator 1) rates too high.