On May 8, 2024, the U.S. Food and Drug Administration (FDA) issued a notice to healthcare providers and facilities regarding ongoing safety and quality concerns with specific cardiovascular medical devices manufactured by Getinge/Maquet. The devices in question are the Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS Sets. The FDA recommends transitioning away from these devices and seeking alternatives where possible due to unresolved risks despite previous corrective actions by Getinge/Maquet.
Devices and Recommendations
The Cardiosave Hybrid and Rescue IABP devices are designed to provide temporary cardiac support through counter pulsation by inflating and deflating intra-aortic balloons in the descending aorta. The Cardiohelp system is used during cardiopulmonary bypass surgeries to oxygenate blood and can be used for up to six hours. The HLS Set, a component of the Cardiohelp system, includes an oxygenator and blood pump.
The FDA’s recommendations for healthcare providers include planning for alternative equipment, reviewing previous FDA recommendations and urgent notices from Getinge, reporting issues or adverse events with Getinge devices to the FDA, and reporting any supply chain issues to the FDA’s device shortages mailbox.
Background and Recalls
Cardiosave IABP Devices:
- Between January 1, 2023, and April 11, 2024, Getinge initiated 12 voluntary recalls for the Cardiosave IABP in the U.S., eight of which were classified as Class I recalls, indicating the most serious type of recall.
- In the last 12 months, the FDA received 2,964 medical device reports (MDRs) related to these devices, including 15 reports of serious injury or death.
- The FDA has been monitoring these devices since 2017, noting issues such as device shutdowns and blood entering the device, which can lead to helium emboli or exposure to patient blood.
- On March 1, 2024, the European Union’s TÜV SÜD temporarily suspended the CE certificate for Getinge’s Cardiosave IABP, preventing its sale in countries requiring CE certification until corrective actions are taken.
Cardiohelp System and HLS Sets
- From January 1, 2023, through April 11, 2024, Getinge initiated eight voluntary recalls for the Cardiohelp system, with one being a Class I recall.
- The FDA received 246 MDRs related to the Cardiohelp system and HLS Set in the last 12 months, including 33 reports of serious injury or death.
- Concerns about the sterility of the HLS Set persist, and similar issues led to the removal of another Getinge device, the Quadrox oxygenators, from the U.S. market in May 2023.
FDA Actions
The FDA is actively working with Getinge to address the factors contributing to these device failures and to develop mitigation strategies. Efforts include collaborating with other manufacturers to explore alternative device options for the U.S. market. Additionally, the FDA and the U.S. Department of Justice placed Getinge’s manufacturing sites under a consent decree in 2015, adding the IABP manufacturing site in 2022, to ensure greater oversight and progress towards resolving quality and safety concerns.
Reporting and Contact Information
Healthcare providers are encouraged to report any adverse events or suspected adverse events with the Getinge devices through the FDA’s MedWatch program and comply with Medical Device Reporting (MDR) regulations. By reporting issues promptly, providers can help the FDA better understand and address the risks associated with these medical devices.
For further questions, healthcare providers can contact the Division of Industry and Consumer Education (DICE) at the FDA.
