Birmingham Getinge/Datascope Cardiosave Devices Lawyer

Getinge/Datascope Cardiosave Devices Attorney Serving Alabama

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.

Recall Background:

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 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump demonstrated failure because of the balloon bursting, leaking or being tore and causing a "blood back event"
• The coiled cable connecting the display and base may fail, leading to an unexpected shutdown and inability to restart.

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.