© Reuters. File photo: A sign outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA on August 29, 2020. REUTERS/Andrew Kelly
(Reuters) – The U.S. Food and Drug Administration on Wednesday classified the recall of Swedish medical device maker Getinge’s heart device as the most serious type because its use could lead to death.
Datascope, a division of Getinge, recalled 4,454 medical devices in December resulting in deaths and four serious injuries due to their use. These devices are designed to help the heart pump more blood.
The unit has received 134 complaints related to the device, including unexpected shutdowns. This can cause the balloon to rupture, leak, or burst causing blood to enter the intra-aortic balloon pump during treatment.
“Getinge is developing further instructions for use and may develop long-term design improvements regarding usability and safety,” the company said in an emailed statement. He added that the cost of the recall was not significant.
Getinge said it notified customers to follow clinical guidance in December.