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, ...
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

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 ...
MD&M East

Getinge Cardiovascular Devices Again Under FDA Microscope

Getinge is once again under scrutiny from FDA related to the company’s cardiovascular devices. The agency today sent a letter to healthcare providers highlighting continued safety and quality concerns ...
Business Wire

MAQUET Medical Systems USA Showcases CARDIOSAVE®™ IABP HYBRID & RESCUE at National Event Committed to Healthcare Innovation

WAYNE, N.J.--(BUSINESS WIRE)--CARDIOSAVE ® IABP HYBRID & RESCUE was one of 14 medical innovations on display in front of thousands of healthcare providers and experts at the Premier healthcare ...