Boston Scientific Recalling Catheters after Reports of Injuries
Boston Scientific is recalling its IMAGER 5F Angiographic Catheters after learning of at least nine reports of injuries associated with the devices. On April 6, 2020, the U.S. Food and Drug Administration (FDA) announced that all models of the angiographic catheters manufactured by Boston Scientific were recalled due to the potential for the tip of the catheter to separate, possibly causing serious adverse health consequences, and even death. Accordingly, the FDA has labeled this a Class I recall, its most serious designation, which is reserved for products that pose a reasonable probability of severe injuries or death.
Angiographic catheters are thin plastic tubes used to deliver contrast agents — a dye — into arteries to make the arteries visible on x-ray images. The affected Boston Scientific catheters have been reported to lose their tips during patient procedures or procedure prep. The tip of the catheter, if separated, could enter the patient’s bloodstream. The detached catheter tips – or attempts to remove the tips – could result in obstruction of blood flow (embolism), stroke, and death.
If you or a loved one suffered injuries you suspect were caused by the Boston Scientific IMAGER II 5F Angiographic Catheter, contact one of our experienced Cincinnati medical device attorneys today. Burg Simpson’s compassionate team of lawyers is prepared to seek justice and compensation for your injuries, even if it means taking on the largest manufacturers in the world. Call 513-852-5600, or fill out our contact form for a FREE no-obligation consultation today.