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All product recalls associated with Boston Scientific Corporation One Boston.
Total Recalls
1000
Past Year
442
Class I (Serious)
138
Most Recent
Dec 2025
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.
Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.
Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.
Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.