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 ...
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S.
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” ...
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 ...
SAN FRANCISCO, CA—A novel percutaneous ventricular assist device (pVAD) appears to offer comparable safety to an intra-aortic balloon pump (IABP) when offering hemodynamic stabilization in elective, ...
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 ...
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 ...
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 ...
An intra-aortic balloon pump is a temporary treatment to help the heart pump enough blood around the body, which people with certain heart conditions may require. An intra-aortic balloon pump (IABP) ...
(Reuters) -The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's heart devices in patients as they faced safety and quality concerns ...