CE mark suspended for troubled heart devices due to ongoing issues
Getinge’s Cardiosave intra-aortic balloon pumps (IABPs) have been the subject of multiple U.S. Food and Drug Administration (FDA) recalls in recent months, including one in January and another in March, and those issues are now impacting sales outside of the United States as well.
TÜV SÜD, a German company that serves as a notified body for medical devices sold and distributed in Europe, is suspending the CE mark for Getinge’s Cardiosave IABPs. TÜV SÜD gave the company three months to provide solutions to the ongoing problems.
During this temporary suspension, Getinge and its subsidiaries are not able to sell the affected devices to customers in countries that require the certificate. The company estimated that this represents approximately $1.7 million in sales.
Devices already on the market can still be used during the suspension, and devices already being distributed to a customer can still be delivered.
“Getinge is aware of the severe situation this suspension puts on healthcare providers and critically ill patients,” Getinge said in a prepared statement. “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. Given the information Getinge has today, the financial impact is not expected to be material.”
Reviewing the IABP recalls
The January recall was due to a risk of blood entering the IABPs through a damaged catheter. A total of 134 issues had been reported at the time of the recall; this included four serious injuries and one patient death. Additional information from the FDA is available here.
The March recall was due to a risk of the devices shutting off with no warning. These unexpected shutdowns were linked to 44 customer complaints, but no serious injuries or deaths. Additional information from the FDA is available here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.