The FDA determined that Getinge’s recall of its Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind.
Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in adults who have acute coronary syndrome or complications of heart failure.
According to an FDA release, the affected devices were manufactured between December 2011 and the present — and distributed between March 6, 2012, and Oct. 21, 2021. The Swedish medtech company initiated the recall on Oct. 27, 2021.
So far, 4,338 devices have been recalled in the U.S., with one death and 71 complaints related to the device issue, which the FDA confirmed is fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy, the regulatory body said.
Getinge sent an urgent medical device correction letter on Nov. 15 to tell customers to immediately determine if they have affected devices within their inventory. Users were instructed to never place fluids on top of the unit and, in case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists.
Additionally, users were told to use “Plastic Weather Display” and “Rescue Cover” functions any time the device is used outdoors, especially when there is the possibility of wet weather. Customers will receive redesigned display and rescue covers for the transport console.
Getinge plans to correct all IABP devices in the field to include internal and external component upgrades. The upgrades will be made available in an ingress prevention upgrade kit and will be installed by a Getinge service representative.
The FDA updated the recall on Dec. 22, confirming that it recently became aware of the affected devices potentially failing to recognize AC/wall power when devices are plugged in, which may lead to devices unexpectedly shutting down. That could lead to serious patient injury or death.
According to the updated recall notice, FDA remains concerned about device shutdown events related to the issue, but recognizes that the systems may be the best option for circulatory support for some patients.
This story was updated with additional information provided by the FDA on Dec. 22, 2021.