The US Food and Drug Administration (FDA) today issued a letter to healthcare providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components.
The FDA is instructing healthcare facilities to avoid using two heart devices from Getinge amid concerns that the company has not adequately resolved issues that spurred a string of recalls over the ...
The FDA on Jan. 25 announced a class 1 recall of Datascope/Getinge’s Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump after one death and four serious injuries were reported. A class 1 recall ...
Getinge AB reported that intraortic balloon pumps (IABPs) manufactured by its Datascope subsidiary are in short supply following a recall of some of these devices in 2019. Getinge said manufacturing ...
(UPDATED) The Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) have been placed under recall by the manufacturer (Getinge/Datascope/Maquet) following reports of fluid leaks, ...
Today, Getinge announces that the EU Notified Body TÜV SÜD has reinstated the EU CE Mark for Getinge's Cardiosave Intra-Aortic Balloon Pump (through the issuance of an updated EU Medical Device ...
Datascope/Maquet have initiated a worldwide recall of certain intra-aortic balloon pump (IABP) systems to address potential electrical test failures. The action involves CS100, CS100i, and CS300 IABPs ...
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