Loading...
Loading...
All product recalls associated with Boston Scientific Corporation.
Total Recalls
546
Past Year
59
Class I (Serious)
3
Most Recent
Sep 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.
Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.
Product malfunction causes inadvertent delivery of energy.
The tines may detach from the core wire during use, which may result in bleeding or soft tissue trauma requiring medical intervention.