Boston Scientific Discontinues Imager II Angiographic Catheters After Detachment Risk
Boston Scientific plans to stop selling certain angiographic catheters after a manufacturing problem led the company to pull the devices from the market. It told customers to immediately stop using or distributing all Imager II Angiographic Catheters due to an issue that can increase the risk of tip detaching. The FDA posted an early alert, noting the fragment could cause life-threatening blockage. Boston Scientific said no new tip detachment complaints were found but the lots were made outside design specification.
Coverage (5)
- Boston Scientific recall of spinal cord stimulator leads tied to more than 1,000 injuries (medtechdive.com)
- Boston Scientific discontinues angiographic catheter sales after recall (massdevice.com)
- Boston Scientific halts sales of angiographic catheters amid 2 serious injuries (fiercebiotech.com)
- Boston Scientific discontinues angiographic catheters (medtechdive.com)
- Boston Scientific discontinues angiographic catheters (yahoo.com)