The FDA is giving healthcare providers recommendations on how to continue safe use of recalled Cardiosave Intra-Aorta Balloon Pumps due to a lack of alternative devices on the market.
About 4,500 Cardiosave intra-aorta balloon pumps have been recalled due to the risk of battery failure and unexpected shutdowns.
More than 4,000 Cardiosave intra-aortic balloon pumps are being recalled after being linked to severe injuries, malfunctions, and at least one death.
More than 2,000 intra-aortic balloon pumps have been recalled due to battery failure risks which could endanger heart patients.
The FDA warns that recalled Cardiosave Intra-aortic Balloon Pumps could lead to serious injuries and deaths following reports of one death and more than 70 incidents.
A new study finds that implanting heart stent patients with an LVAD system increases the risk of death and complications compared with intra-aortic balloon pumps.
An intra-aorta balloon recall comes following several patient deaths after the heart devices burst or ruptured.
A Marquet/Getinge intra-aortic balloon pump recall comes following revelations that the devices may not work properly at higher altitudes.
The prominent consumer watchdog group Public Citizen is calling on federal regulators to require that all intra-aortic balloon pumps (IABP) be put through rigorous clinical trials before being placed on…
