FDA Expands List of Getinge IABP System and Component Shortages
The US Food and Drug Administration (FDA) today issued a letter to healthcare providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components.
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.
Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.
Source: Read Full Article