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All product recalls associated with Boston Scientific Corporation.
Total Recalls
1000
Past Year
1000
Class I (Serious)
34
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
Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection.
St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in embolization.