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 ...
Medscape

FDA Spotlights Woes With Getinge’s Recalled IAB Pumps

The US Food and Drug Administration (FDA) is updating healthcare providers on device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pumps (IABPs), including the Cardiosave ...
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 ...
TCTMD

Fluid Leaks Spark Recall of Cardiosave Hybrid, Rescue IABPs

(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, ...
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” ...
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 ...
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 ...
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 ...
Healio

Irbesartan, IABP, INR test strips recalled

Please provide your email address to receive an email when new articles are posted on . The FDA issued alerts about recalls of irbesartan lots, an intra-aortic balloon pump and test strips used with ...
News Medical

Intra-aortic balloon pump support reduces 30-day mortality in postinfarction VSR patients

Announcing a new article publication for Cardiovascular Innovations and Applications journal. An intra-aortic balloon pump (IABP) is the device most frequently used as a bridge to surgical repair in ...
Yale Environment 360

High-tech pump may increase risk of death and bleeding, study finds

A new national study finds that use of the Impella circulatory support device is associated with higher rates of death and major bleeding than a common alternative, especially among patients with ...
News Medical

Study finds no benefit of early IABP use in cardiogenic shock patients

Compared with standard medical care, early use of a temporary intra-aortic balloon pump (IABP) to support heart function in patients who were critically ill with cardiogenic shock caused by heart ...