Getinge announced today that European regulatory authorities reinstated the CE mark for its Cardiosave intra-aortic balloon pump.
The Swedish medtech company faced a temporary suspension for the technology in March 2024. That suspension, initially slated to last six months, expanded through July 1, 2025.
Getinge faced the suspension due to gaps in compliance with the applicable medical device directive. Specifically, TÜV SÜD requested that the company accelerate the implementation of product improvements to address open field safety corrective actions. Those safety actions extended around the world as, last year, the FDA issued a letter to health care providers and facilities expressing “continued safety and quality concerns” about the cardiovascular medical devices.
The company had initiated 12 voluntary recalls for the Cardiosave IABP From Jan. 1, 2023, through April 11, 2024. That included eight classified by the FDA as Class I recalls, the most serious type.
Now, Getinge has TÜV SÜD approval for multiple design improvements to the devices. It plans to implement the improvements into production and into its service program for installed devices. The company expects to make those design enhancements available to other markets upon approval by respective health authorities.
Getinge expects to resume Cardiosave deliveries in Europe in the fourth quarter.
“We are aware of the challenges the CE-mark suspension has caused for healthcare professionals and patients. Our teams have worked persistently to adhere to the required corrective actions in close dialogue with our Notified Body, TÜV SÜD,” said Elin Frostehav, president, Acute Care Therapies at Getinge. “Ensuring that healthcare professionals and patients have access to our life-saving devices remains our number one priority and we are pleased to achieve CE-mark reinstatement which enables us to again provide this device to customers in countries accepting the EU CE-mark to help improve cardiac outcomes.”
