Earlier this week, the agency announced shortages of the company’s Maquet/Datascope IAB catheters, new Cardiosave IABP devices, and Cardiosave IABP parts. The new notification adds Getinge Maquet/Datascope IABP systems to the list.
The company’s letter explains that “ongoing supply chain issues have significantly impacted our ability to build intra-aortic balloon pumps, intra-aortic balloon catheters, and spare parts due to raw material shortages.”
It also offers guidance on maintaining Cardiosave Safety Disks and lithium-ion batteries in the face of the shortages. “In the event that you need a replacement pump while your IABP is undergoing service, please contact your local sales representative who may be able to assist with a temporary IABP.”
Providers are instructed to inform the company through its sales representatives “if you have any underutilized Maquet/Datascope IAB catheters or IABPs and are willing to share them with hospitals in need.”
The shortages are expected to continue into 2023, the FDA states in its letter.