As a law firm specializing in defective medical device litigation, we understand the legal complexities that arise when medical devices are recalled. The recent recall by Datascope/Getinge of certain Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) has significant legal implications for healthcare facilities, professionals, and patients.
The Getinge/Datascope Cardiosave Hybrid and Rescue IABP recall was initiated due to potential malfunctions that could compromise the circulatory support provided by these devices to patients with severe cardiac conditions. This recall has raised concerns about patient safety and may result in legal challenges for healthcare providers and patients who have been impacted by the use of these devices.
There have been at least two (2) FDA Class 1 recalls of the devices due to following issues.
The Datascope recall is Class I, the most serious type of recall, indicating that there is a reasonable probability that the device could cause serious injury or death. In the event a loved one has passed, a Birmingham wrongful death lawyer can help.
The CardioSave Hybrid/Rescue Intra-Aortic Balloon Pumps (IABP) are cardiac (heart) assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.
IABPs are therapeutic devices that control blood flow from the heart by helping the heart pump more blood. The electromechanical systems are used in health care facilities to inflate and deflate intra-aortic balloons, for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. A thin, flexible catheter connects a balloon to a computer console. The balloon is positioned in the aorta. The pump is then set to make the balloon inflate and deflate in accord with the cardiac cycle.
The Getinge/Datascope devices are used on adult patients in healthcare settings and help treat acute coronary syndrome, heart failure complications, and are implemented during both cardiac and non-cardiac surgery.
Some of the potential side effects caused by a defective Cardiosave Hybrid Intra-Aortic Balloon Pump IABP and Rescue IABPs may include the following:
If you think that you have been victimized by a Datascope Cardiosave Hybrid Intra-Aortic Balloon Pump and Rescue IABPs you may be entitled to fair compensation. Contact DeGaris Law today for a free consultation with a Birmingham defective medical device attorney regarding your legal rights.