August 14, 2023
After its M&A news in early summer, it looked like things were finally starting to turn around for Getinge in 2023. However, that doesn’t seem to be the case as the company has again been hit with a regulatory blow, this time in the shape of yet another Class I recall.
The recall relates to its Cardiosave Hybrid Intra-Aortic Balloon Pump and Cardiosave Rescue Intra-Aortic Pump, which are “electromechanical systems used to inflate and deflate intra-aortic balloons to provide temporary support to the left ventricle through counter pulsation,” according to the recall notice. Once positioned correctly, the pump synchronizes with the electrocardiogram or arterial pressure waveform to make the balloon inflate or deflate at the correct moment during the cardiac cycle. The pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of adult heart failure.
Getinge stated in the recall that the pumps have a risk of shutting down unexpectedly due to electrical failures in the devices power management board or solenoid board. The recall is rated as Class I based on its potential for serious adverse health events, including unstable blood pressure, inadequate blood supply, a vital organ injury, or death. Currently Getinge has reported 26 complaints and there have been no reports of injury or death. The recalled devices were distributed between March 6, 2012, and May 9, 2023.
The announcement is far from Getinge’s first regulatory blow of 2023, in fact, it’s not even the first Class I recall for its Cardiosave Hybrid and Rescue in 2023. In late March, the company confirmed it was recalling the pumps because the coiled cable connecting the display and base on some units had the potential to fail, causing unexpected shutdowns without warning or alarm to alert the user. At the time, the company saw 44 complaints about the damaged coils but didn’t receive reports of injury or death related to the issue.
The pump problems are in addition to the company’s years-long process to rectify sterile packaging breaches in its life support systems. In late 2020, Getinge started a voluntary recall of its heart-lung support (HLS) set advanced devices after discovering that “a limited number” of more than 58,000 systems distributed worldwide since October 2018 could have arrived with damage to its sterile packaging. However, in July 2022, the company expanded the recall to cover additional product codes and lot numbers of the HLS systems, growing the number to 67,000 devices.
Then, in December 2022, Getinge put out a field safety notice announcing that it had placed a voluntary shipping hold on its HLS and permanent life support (PLS) set which are sold through its Maquet subsidiary.
The hold was in response to the company stating it had addressed all possible nonconformities with its sterile packaging. An unnamed regulatory body, however, disagreed and determined that tests of the updated packaging had been inadequate. The company also issued an Urgent Medical Device Correction in February 2023 about potential problems with packaging sterility for the HLS, and FDA released a Letter to Healthcare Providers on the matter on March 1.
And FDA wasn’t the only regulatory thorn in Getinge’s side.
Also in March, the company was hit with a particularly heavy penalty when DEKRA, a German-based notified body, announcing that the CE certificates for the HLS and PLS systems would be suspended, preventing the company from shipping out any unsold systems in Europe.
“According to DEKRA the documentation related to the initiatives submitted from Getinge does currently not demonstrate compliance with the essential requirements according to the Medical Device Directive and applicable standards,” Getinge wrote in a release at the time. “As a result, DEKRA will temporarily suspend the certificates for the HLS and PLS sets from March 1, 2023.”
That same month, as part of the initial pump Class I recall, the Hybrid and Rescue devices also had their CE mark suspended.
At the beginning of summer, it seemed the company was finally reaching a bright spot in 2023 after announcing its proposed acquisition of High Purity New England (HPNE), a single use assembly supplier, for about $120 million.
However, with the recent announcement of another Class I recall, it begs the question of whether the HPNE M&A be the only silver lining for the year.
About the Author(s)
You May Also Like