By Dominic Chopping

STOCKHOLM--Getinge shares are under pressure Wednesday after the company said it will limit sales of some of its heart devices in the U.S. as regulators recommended healthcare providers to transition away from the products.

At 1222 GMT shares were toward the bottom of the Stoxx Europe 600 index, falling 12% on the day to SEK190.55.

The U.S. Food and Drug Administration last week recommended providers to 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, over safety and quality concerns. It recommended use of the products only if there were no other alternatives available.

The Swedish medical technology company has been struggling to correct problems with the devices for nearly a year, in addition to issues with sterile packaging, which has dented earnings and sent its shares down 23% in the last 12 months.

"We have decided to immediately pause promotional activities of the Cardiohelp System and Cardiosave Intra-Aortic Balloon Pump in the U.S. until outstanding actions related to quality improvements have been addressed and approved," Getinge Chief Executive Mattias Perjos said in a statement late Tuesday.

"The sale of these hardware products will be limited to customers who have no available alternatives."

These decisions will likely have a negative financial impact until new next-generation devices are approved and launched, so the company hasn't provided organic net sales growth or adjusted earnings before interest, tax and amortization margin targets for the period to 2028.

However, it said organic net sales growth during the period should be between 3% and 6% with an Ebita margin of between 16% and 19% at the end of the period. It expects adjusted earnings per share growth of above 12% on average between 2024 and 2028.

"Given the recent blows from the FDA and the fact that 2028 is a long way off, we're not convinced how useful these targets are at this stage," Kepler Cheuvreux analyst Oliver Reinberg said in a note.

The potential impact from the company limiting sales is difficult to judge, and Reinberg notes that no new strong measures were outlined to deal with the quality problems, which appear to be increasingly persistent.

"Our best guess is that the consensus must come down by around 100 basis points on the margin and 10% on adjusted earnings per share for both 2024 and 2025," he added.

Write to Dominic Chopping at

(END) Dow Jones Newswires

05-15-24 0844ET