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March 29, 2023
2 Min Read
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Getinge's regulatory troubles deepened this week with another CE mark suspension, this time for the intra-aortic balloon pumps (IABPs) that is part of a class I recall in the United States.
In recent months the Gothenburg, Sweden-based medical device manufacturer has faced supply chain issues, sterile packaging problems, two previous CE mark suspensions, and the FDA class I recall.
Getinge said the notified body for certification services, TÜV SÜD, has decided to suspend the CE-certificate for its Cardiosave intra-aortic balloon pump, effective immediately. The company has been given three months to adhere to the required corrective actions. The suspension is based on concerns related to risk management, post market surveillance and vigilance, as well as information pertaining to timeliness of field safety corrective actions.
During the three months, Getinge will not be able to provide balloon-pumps to customers requiring CE certificate, which represents about 70 million Swedish krona (or $6.7 million) of the annual sales of the Cardiosave pumps. The temporary suspension does not impact devices already on the market or in distribution, the company said. Balloons and spare parts are not affected.
"Getinge is aware of the severe situation this suspension puts on healthcare providers and critically ill patients," Getinge stated. "The company is in dialogue with TÜV SÜD and working urgently to minimize the impact on patients. All affected customers will receive communication from Getinge."
The company said it does not expect the financial impact of this action to be material, based on the information it has today.
Getinge recently recalled its Cardiosave Hybrid IABPs and Cardiosave Rescue IABPs from the U.S. market because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user. Once the error occurs, the coiled cord needs to be replaced for the device to work again. The issue may occur in units distributed before July 24, 2017, according to the recall notice FDA posted last week.
The Cardiosave Hybrid IABP and the Cardiosave Rescue IABP are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle. Cardiosave IABPs are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. They are used in healthcare facilities.
FDA said an unexpected pump shutdown and any interruption to therapy that occurs can lead to unstable blood flow (hemodynamic instability), organ damage, and/or death, especially for people who are critically ill and most likely to receive therapy using these devices.
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