Only a month after Getinge announced the suspension of the CE marks allowing it to sell its heart-lung support and permanent life support systems in Europe, the Swedish devicemaker has temporarily lost another EU green light.
Getinge will not be allowed to sell its Cardiosave intra-aortic balloon pumps in Europe for up to three months, the company announced this week—though pumps already on the market can continue being used. The decision took effect immediately and was delivered by TÜV SÜD, a notified body based in Germany.
The suspension was based on a range of issues linked to Getinge’s “risk management, post-market surveillance and vigilance” related to the pump, and to the company’s response to certain field safety corrective actions regarding the device, it said in its release. Getinge will spend the three-month suspension period working to rectify those issues.
Though the company noted in the announcement that sales of the pump in countries requiring CE mark approval bring in about 70 million Swedish krona (or $6.7 million U.S.) per year, it said that the financial effect of the suspension “is not expected to be material.”
The Cardiosave balloon pumps are inserted into the aortas of patients recovering from interventional heart surgeries, heart attacks and other major cardiac events. The devices help the heart keep pumping blood normally throughout the body by repeatedly inflating and deflating to control blood flow from the heart.
The CE mark suspension isn’t the first setback the pumps have faced in recent months. In December, Getinge began a recall of the pumps that was ultimately given the FDA’s most serious Class I rating a month later.
The recall came after Getinge discovered that if the balloon is torn, burst or otherwise damaged, it could let blood into the pump during use, causing the whole mechanism to shut down without warning. Not only could that lead to blood loss, organ damage or even death, but it may also allow helium from the pump to leak into the bloodstream and create gas bubbles in the veins.
Plus, if a damaged pump isn’t properly inspected and is reused on another patient, any blood that was trapped inside the balloon could potentially leak out and contaminate the bloodstream of the new user.
By the time the FDA slapped its Class I label on the safety event, Getinge had collected 134 complaints related to the issue, five of which included reports of adverse events—comprising four serious injuries and one patient death. In total, the recall spans nearly 8,800 of the pumps distributed around the world, more than half of which had been sold in the U.S. since March 2012.
This also isn’t the first CE mark suspension this year for Getinge. Last month, it reported that another German notified body, DEKRA, had temporarily revoked another European approval after the company failed to adequately correct issues with the sterile packaging for its HLS and PLS systems.
Getinge has been working to fix those issues since at least 2020 when it began a recall of some HLS devices that had been shipped with damage to their sterile packaging. Though the company went on to expand that recall last year, it assured customers that it had been shipping out its life support systems with “more durable” packaging since the fall of 2021 and that it hadn’t received any reports of injuries or deaths associated with sterility breaches.
In the wake of the recalls, Getinge closed out 2022 by placing a voluntary shipping hold on the HLS and PLS systems. At the time, the company said it had addressed all possible risks to the sterility of the packaging, but that an unnamed regulator had decreed that Getinge’s tests of the updated packaging hadn’t been sufficient. Getinge said it was rushing to perform additional tests, with results expected in April.