As of December 2, 2022, Getinge Maquet/Datascope Intra-Aortic Balloon Bump (IABP) devices were added to the FDA’s medical device shortage list as officials worked to inform healthcare facilities and providers. The shortage, first called to attention by Getinge on November 29, 2022, points to “limited supplies of IAB catheters, new Cardiosave IABPs, and Cardiosave IABSP parts.”
Commonly used by patients recovering from heart surgery or a cardiac event, an intra-aortic balloon pump (IABP) is often a life-saving device that controls blood flow from the heart. It deflates when the heart pumps blood out and inflates as the heart rests between beats, and it helps regulate the organ when it cannot contract and relax on its own. Connected to a machine that delivers small bursts of helium to inflate the balloon, the IABP is placed in a patient’s thoracic aorta, part of the large artery in the chest that conveys blood from the heart to other areas of the body.
During an intra-aortic balloon pump placement, healthcare providers insert a hollow tube (catheter) into a patient’s leg artery, then guide the balloon through the catheter. X-ray imaging is then used to help navigate the balloon and the catheter up to the aorta. Lastly, the intra-aortic balloon pump is affixed to the machine, which directs the balloon to inflate and deflate. Patients are typically on the IABP for a few days after placing the device.
In response to the shortage, the FDA is advising all healthcare facilities and providers who use the Getinge Maquet/Datascope IAB catheters or IABP devices as follows:
- Read the original notification from Getinge. This letter contains temporary maintenance updates regarding the Cardiosave IABP Safety Disk and Lithium-Ion Battery.
- Report to their Getinge Sales Representative of any extra/underutilized Maquet/Datascope IAB catheters or IABPs that may be shared with other facilities in need.
- Report to the FDA any problems with Getinge Maquet/Datascope IAB catheters or IABP devices.
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