May 8 (Reuters) - The U.S Food and Drug Administration

(FDA) on Wednesday advised healthcare facilities to move away

from using Getinge's 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.

The health regulator said although alternative treatment

options were limited, it was still recommending the switch 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 did not immediately respond to a Reuters'

request for comment.

Getinge initiated 12 voluntary recalls in the U.S. for

the device 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.