The U.S. Food and Drug Administration (FDA) has announced that Datascope, a subsidiary of Getinge, is recalling certain Cardiosave intra-aortic balloon pumps (IABPs) due to a risk that the devices could stop working unexpectedly. This is a Class I recall, which means the FDA believes using one of these IABPs “may cause serious injuries or death.”
These devices are designed to provide temporary support to a patient’s left ventricle. Electrical failures have caused some of them to turn off with no warning, however, putting the patient’s health at immediate risk.
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death,” according to the FDA’s advisory.
The recall includes a total of 4,586 Cardiosave Hybrid IABPs and Cardiosave Rescue IABPs distributed in the United States from March 2012 to May 2023. A total of 26 complaints have been reported due to this issue, though there have been no reports of injuries or deaths.
Customers have been advised to ensure they have an alternative IABP available so that they can continue providing care as necessary. If no other devices for counterpulsation therapy are available, the FDA advisory said, customers should “provide alternative hemodynamic support.”
The Cardiosave Rescue Intra-Aortic Balloon Pump.
A history of problems for Cardiosave Hybrid and Rescue IABPs
This is the fourth recall in 2023 for these devices. The first was announced in January, when more than 4,400 devices were recalled due to a risk of blood entering the IABP through a damaged catheter.
The second recall of 2023, announced back in March, and third recall of 2023, announced in April, were also due to a heightened risk that the devices may stop working unexpectedly.
In related news, TÜV SÜD, a German company that serves as a notified body for medical devices sold and distributed in Europe, said in March that it was suspending the CE mark for Getinge’s Cardiosave IABPs for three months.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.