Getinge's iCast™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.
The U.S. Food and Drug Administration (FDA) on Friday classified the recall of Getinge AB's heart devices as the most serious type, saying their use may cause injuries or death. The Swedish medical equipment maker's unit, Datascope, recalled an estimated 2,300 devices in the United States in January. Coiled cable connecting the display and base on some devices of the company may fail, causing an unexpected shutdown, according to the FDA.
The U.S. Food and Drug Administration on Wednesday classified the recall of Swedish medical equipment maker Getinge's heart devices as its most serious type since their use could lead to death. Datascope, a unit of Getinge, had recalled 4,454 therapeutic devices in December following a death and four serious injuries from their use. The unit has received 134 complaints related to the devices, including unexpected shutdowns, which can cause a burst, leak, or torn balloon leading blood to enter the intra-aortic balloon pump during therapy.