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” ...
Yahoo Finance

FDA issues warning on Getinge device amid quality concerns

The US Food and Drug Administration (FDA) has urged healthcare providers not to use certain Getinge devices amid concerns that the company’s devices still pose a risk to users despite a previous ...
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 ...
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 ...
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 ...
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 ...