Dive Brief:
- The Food and Drug Administration in a letter Wednesday told healthcare providers and facilities they should stop using certain Getinge cardiovascular medical devices.
- Getinge has initiated 20 recalls related to problems with balloon pumps and cardiopulmonary bypass devices in less than 16 months, according to the notice.
- The FDA is concerned Getinge has yet to “sufficiently” address the problems and risks, leading it to advise users to “plan for alternative capital equipment to transition away” from the devices.
Dive Insight:
Getinge’s Cardiosave intra-aortic balloon pumps and Cardiohelp cardiopulmonary bypass devices have faced repeated quality problems and regulatory actions. Over the first eight months of 2023, Getinge temporarily lost CE marks for life support sets and heart pumps and initiated U.S. recalls of both groups of products.
The FDA quantified the quality problems in its latest action. Over the past 12 months, the agency has received nearly 3,000 medical device reports about the balloon pumps, including 15 that described a serious injury or death. Getinge initiated 12 Cardiosave recalls in under 16 months starting in January 2023, including eight the FDA labeled Class I recalls.
The FDA began reviewing reports of devices shutting down in 2017 and has since identified other issues.
Meanwhile, users have submitted 246 medical device reports about Cardiohelp systems, including the HLS set component, both of which are referred to in the letter. Thirty-three reports of serious injury or death have been tied to the Cardiohelp system, including the HLS sets, according to the notice. Getinge started eight recalls in the 16 months starting January 2023, one of which was a Class I recall.
The FDA sent letters last year to advise healthcare professionals to have back up balloon pumps available and consider using alternatives to Cardiohelp. Getinge took corrective steps, but the FDA continued to receive medical device reports related to the problems, leading it to make stronger recommendations in its latest letter.
The agency cited the temporary suspension of the CE mark for Cardiosave in the letter. In March, the notified body Tüv Süd gave Getinge six months to take corrective actions after finding the company had only partially fulfilled conditions imposed when the certificate was reinstated in 2023.
Getinge CEO Mattias Perjos discussed the CE mark suspension on an earnings call in April.
“We haven't been fast enough when it comes to implementing some of the field safety actions that are needed in certain geographies,” the CEO said. “Those delays were triggered by a lack of components that we had during the first half of last year. So those are now mitigated, and we're in a much, much better situation to do the field safety actions with better speed.”
Perjos was “cautiously optimistic” that Getinge would be able to do “that part of the remediation work” but declined to provide detailed guidance. While Getinge was clear on what needed to be done, the CEO said “it's a little bit difficult to forecast the pace.”
