US FDA advises healthcare facilities to switch from Getinge's heart devices
Adds details in paragraphs 5 & 6, background throughout
May 8 (Reuters) -The U.S Food and Drug Administration (FDA) on Wednesday advised healthcare facilities to move away from using Getinge's GETIb.ST heart devices in patients as they faced safety and quality concerns despite a string of recalls.
The recommendation is based on concerns that the company has not sufficiently addressed the problems and risks with the recalled devices, it added.
Getinge did not immediately respond to a Reuters request for comment.
The FDA suggests providers to move away from the use of Getinge's Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and its Cardiohelp system and HLS Sets.
The health regulator recommends providers to transition away from these Getinge cardiovascular devices and use alternative devices if possible.
The Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump IABP are electromechanical systems that inflate and deflate balloons in the aorta to provide temporary support to the left ventricle.
Getinge initiated 12 voluntary recalls in the U.S. for the devices between Jan. 1, 2023 and April 11, 2024. Of these recalls, eight were classified as the most serious.
In the last 12 months, the health regulator has received 2,964 medical device reports related to Cardiosave Intra-Aortic Balloon Pumps, of which 15 were reported as resulting in patient death or serious injury.
The company's Cardiohelp system pumps blood out of the patient to oxygenate the blood during cardiopulmonary bypass surgeries. The HLS Set is an oxygenator and blood pump, which is a disposable component of the Cardiohelp system.
From January 1, 2023, through April 11, 2024, Getinge initiated eight voluntary recalls for the Cardiohelp system, including the HLS Set.
The FDA received 246 reports related to the device, in the last 12 months, of which 33 were reported as resulting in patient serious injury or death.
The FDA said it recognizes that alternative treatment options are limited. It added it is working with other manufacturers to assess their ability to manufacture and distribute alternative devices.
Reporting by Sriparna Roy in Bengaluru; Editing by Anil D'Silva and Shailesh Kuber
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