Medtronic has recalled its Rashkind balloon catheter after reports of a patient death and two patient injuries, the FDA announced Nov. 3.
The catheter is used as part of treatment for people with congenital heart defects. Medtronic said it is recalling the device because of quality issues that may lead to the device breaking, separating or failing during use. This could cause serious adverse effects, such as blood vessel damage or death.
Medtronic said it has received reports of two patient injuries and one patient death related to the recall and has stopped making and distributing the device due to reasons unrelated to the recall.
Read the FDA's full recall notice here.