Dive Brief:

• Getinge faces its second Class I recall of the year related to its Cardiosave intra-aortic balloon pumps.
• Amid the suspension of sales of the devices in the European Union, the Food and Drug Administration classified a fault that results in unexpected shutdowns that may cause serious injuries or death. Getinge has received 42 complaints but no patients have been seriously harmed, according to the FDA notice. 
• The recall is the latest in a series of compliance problems for Getinge, which has had CE marks for two products suspended.

Dive Insight:

Getinge issued an Urgent Medical Device Correction letter about the unexpected shutdown problem in February. The FDA added the recall to its database in early March and followed up with a statement detailing the situation on Friday.

In the statement, the FDA describes a fault with Getinge’s Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue IABP, devices that are used to pump the heart during surgery and in patients with certain serious cardiovascular problems, such as acute coronary syndrome. The fault stems from the loss of communication between two printed circuit board assemblies (PCBAs).

When communication between the pump’s executive processor PCBA and video generator PCBA is lost, the device may unexpectedly shut down without triggering a warning or alarm to alert the user. One or both of the PCBAs must be replaced for the device to work again after the unexpected shutdown.

The categorization of the fault as a Class I recall reflects the vulnerability of patients who need the heart pump. Because the device is used in people who are undergoing surgery or are critically ill, unexpected pump shutdown and the interruption of therapy may cause unstable blood flow, organ damage or death.

Getinge has developed a software update to address the issue, and a service representative will contact customers to schedule installation of the software when it is available. In the meantime, customers that encounter the fault should use another IABP and contact Getinge.

While Getinge has had repeat run-ins with regulators this year, its share price has climbed 15.9% to 252.70 Swedish kronor ($24.35) in trading in Sweden so far in 2023. The gains have gone some way to reversing the loss the stock suffered between November 2021 and September 2022, when it fell from 420 Swedish kronor to 181 kronor.