Boston Scientific stops sales of Imager II catheters after tip defect linked to two injuries

Boston Scientific issued a letter on August 24 advising customers to remove all Imager II angiographic catheters from use or sale after discovering a manufacturing problem.

The problem involves reduced levels of stabilizing agents in the catheter tips, which could cause tip degradation and detachment.

The FDA warned that detached tip fragments could lead to life-threatening embolism and organ failure. The company has reported two serious injuries but no deaths.

This action follows a prior Class I recall two years earlier for a similar catheter tip issue, adding to a challenging year for the medtech firm.