Dive Brief:
- The U.S. Food and Drug Administration has categorized Getinge’s latest heart assist pump safety notice as a Class I recall.
- Getinge sent an urgent field safety notice in June after receiving 26 complaints about Cardiosave intra-aortic balloon pumps unexpectedly shutting down because of power management or solenoid board failures.
- The issue described in the FDA recall notice is one of two problems covered by the Getinge alert, and has become the third Class I Cardiosave recall of the year.
Dive Insight:
Getinge has faced multiple quality and compliance issues in 2023. The FDA posted Class I recall notices about Cardiosave devices in January and March. In Europe, a notified body suspended the Cardiosave CE mark, temporarily blocking sales of the devices in certain markets. The Cardiosave problems have arisen in parallel to issues with sterile packaging of life support devices, which have been the subject of recalls and a suspension.
This week, the FDA issued another Class I notice about 4,586 Cardiosave devices. The pumps inflate and deflate intra-aortic balloons to provide temporary support to the left ventricle. Because the devices are critical to the management of severely ill patients, faults can cause serious health outcomes.
Getinge has linked the unexpected shutdowns to tantalum capacitor failures in its boards. No physicians have reported adverse events linked to the fault, which has a failure rate of 0.27%, but the potential for a shutdown to cause a serious injury or death led the FDA to assign the recall to Class I.
If an unexpected shutdown happens, Getinge is advising healthcare professionals to continue therapy using another device. Getinge is developing a hardware correction to fix the problem and will contact customers to schedule installation. The company is also developing a hardware fix for the other problem described in the urgent field safety notice. That fault is not referenced in the FDA’s Class I recall notice.