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.