Getinge subsidiary Datascope has recalled thousands of Intra-Aortic Balloon Pumps in 2023, and in the latest notice, the FDA labeled the issue as Class I because of unexpected shutdowns.
On Aug. 10, the FDA said 4,586 devices were recalled because of sudden power failures, which can cause inadequate blood supply and death. Twenty-six complaints, zero injuries and zero deaths have been reported in the recall.
This is the fourth statement the FDA has published in 2023 about the devices. In February, the company notified customers to stop using the pumps because of unexpected shutdowns, the FDA said in separate posts.
The month prior, the FDA said Getinge/Datascope reported a risk of balloons breaking. As of Jan. 25, 134 complaints, 12 device shutdowns, four serious injuries and one death have been reported.