TCTMD

FDA: Class I Recall for Cardiosave Hybrid IABP Due to ‘Fluid Ingress’

The US Food and Drug Administration (FDA) has alerted users of Datascope Corp/MAQUET’s Cardiosave hybrid intra-aortic balloon pump (IABP) to a “design issue” that enables fluids to leak into the ...
TCTMD

Another Recall Warns of Unheralded Shutdowns With Cardiosave IABPs

Another week, another recall for the beleaguered Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) manufactured by Getinge/Datascope—this time due to a “communication loss” ...
Medscape

Another FDA Class I Recall of Cardiosave Hybrid/Rescue IABPs

Datascope/Getinge is recalling certain Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because the coiled cable connecting the display and base on some units may fail, ...
Medscape

FDA Classifies Cardiosave IABP Recall as Class I

Getinge is recalling its Datascope/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) because of reports of fluid leaks. There has been one death and 71 complaints ...
HealthLeaders Media

FDA warns of ‘continued safety and quality concerns’ in Getinge recalls

The warning covers Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets ...
Becker's Hospital Review

Recalled heart device tied to 1 death, 4 serious injuries, FDA says

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 ...
Healio

FDA designates recall of two intra-aortic balloon pumps as class I

Please provide your email address to receive an email when new articles are posted on . Datascope/Maquet/Getinge intra-aortic balloon pumps recalled due to risk for unexpected shutdown. The FDA has ...
Becker's Hospital Review

Heart balloon pumps added to medical device shortage list

The FDA placed some balloon pumps on its medical device shortage list Dec. 2, which the agency said was because of increased demand and shortage of some of the product’s components. There is a ...