FDA announces third recall of 2023 for troubled heart devices
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 heightened risk that the devices could stop working with no warning.
The unexpected shutdowns are being caused by communication issues between the device’s executive processor printed circuit board assembly (PCBA) and video generator PCBA.
“This shutdown will occur without warnings or alarms to alert the user,” according to the FDA’s advisory. “Once the error occurs, one or both of the PCBAs will need to be replaced for the device to work again.”
The advisory warns that any unexpected IABP shutdown can result in significant complications, including organ damage or even death. While there have been 42 complaints so far about the PCBA issues, there have been no serious injuries or deaths.
The recall—the third in three months for these devices—covers both the Cardiosave Hybrid IABP and the Cardiosave Rescue IABP. A total of 4,502 IABPs distributed to customers from Marcy 2012 to January 2023 are included.
Prior issues with Cardiosave intra-aortic balloon pumps
The Cardiosave Hybrid and Rescue IABPs have a history of safety issues that goes back several years. This is the third recall in 2023 alone. Back in January, certain devices were recalled because blood entering the IABPs through a damaged catheter. A total of 134 issues had been reported at the time of the recall, including four serious injuries and one patient death.
A recall announced on March 17 was, like this latest recall, due to a risk of the devices shutting off with no warning. There had been 44 customer complaints had been reported at the time of the recall, but there were no serious injuries or deaths.
Also, TÜV SÜD, a German company that serves as a notified body for medical devices sold and distributed in Europe announced in March that is suspending the CE mark for Getinge’s Cardiosave IABPs for three months. During this temporary suspension, Getinge and its subsidiaries are not able to sell the affected devices to customers in countries that require the certificate.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.