Hospitals across the country have been told to stop using an angiography catheter after the manufacturer determined the devices were built outside their approved design specification. The Food and Drug Administration issued an early alert on August 28 covering Boston Scientific's Imager II Angiographic Catheters, and the company is removing them from the market and discontinuing the product line.
The defect is in the tip. Boston Scientific determined the catheters were manufactured with reduced levels of stabilizing agents in the tips, which may increase the risk that a tip degrades and detaches during use.
