By Ben Glickman

Getinge plans to limit sales of certain cardiovascular devices after U.S. regulators recommended last week that providers transition away from the products.

The Swedish medical-technology company said Tuesday that it would immediately pause promotional activities on its Cardiohelp System and Cardiosave IABP in the U.S. until certain quality-improvement actions are made. The company will only sell the hardware products to customers with no available alternatives.

The U.S. Food and Drug Administration said in a letter May 8 that healthcare facilities should move away from using certain Getinge products, arguing that the company has not sufficiently addressed issues with previously recalled devices.

Chief Executive Mattias Perjos said the company would inform customers about the regulatory requirements for using its Cardiohelp System. Outside of the U.S., Getinge said it had implemented product improvements and would continue to sell the products.

Getinge expects the decisions to stop promotion and limit sales would dent finances until new, next-generation products are approved.

Write to Ben Glickman at

(END) Dow Jones Newswires

05-14-24 1528ET