By Dominic Chopping

STOCKHOLM--Getinge shares trade at the bottom of the Stoxx Europe 600 index after the U.S. Food and Drug Administration advised healthcare providers to move away from using the Swedish company's heart devices amid safety and quality concerns.

In a statement Wednesday, the FDA said it recommended providers find alternatives to Getinge's balloon pump and bypass devices as well as its oxygenator and blood pump systems that are used within the bypass device.

At 0851 GMT Getinge shares were trading 7.4% lower at SEK215.20 as Swedish markets reopened following a public holiday.

The FDA said that between Jan. 1, 2023 and April 11, 2024, Getinge initiated 12 voluntary recalls in the U.S. for its Cardiosave Intra-Aortic Balloon Pump, which is used to provide temporary support to the heart's left ventricle. Eight of the recalls fall within the most serious type under FDA classifications.

It added that in the last 12 months it has received 2,964 medical device reports related to the balloon pumps, and of those, 15 were reported as resulting in patient serious injury or death.

Getinge initiated eight voluntary recalls for the Cardiohelp bypass system, including the oxygenator and blood pump systems between Jan. 1, 2023 and Apr. 11, 2024. One of these was classified as the most serious type of recall.

In the last 12 months, the FDA received 246 medical device reports related to the system, of which 33 were reported as resulting in patient serious injury or death, it said.

The FDA said it is continuing to work with Getinge to understand factors contributing to the device failures, as well as possible mitigation strategies. It is working with other manufacturers to assess their interest and ability to produce and distribute alternative devices in the U.S., as alternative treatment options are currently limited.

"Getinge has been working on these issues, which weighed on the stock last year, for a long time," Kepler Cheuvreux analyst Oliver Reinberg said in a note to clients.

"Now, however, we may see a negative impact from doctors on the important U.S. market. This creates uncertainty."

Getinge didn't immediately respond to a request for comment.

Write to Dominic Chopping at

(END) Dow Jones Newswires

05-10-24 0525ET