Critical Safety and Quality Concerns with Getinge Cardiovascular Devices

FDA Urges Healthcare Providers to Transition Away from Getinge’s Recalled Devices

The U.S. Food and Drug Administration (FDA) recently issued an urgent warning to healthcare providers regarding serious safety and quality concerns with several cardiovascular devices manufactured by Getinge/Maquet. Specifically, the FDA highlighted issues with the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Cardiohelp system and HLS sets. The agency recommends healthcare facilities transition away from using these devices and seek alternatives whenever possible, citing ongoing risks and unresolved problems despite previous corrective actions taken by Getinge.

From January 1, 2023, to April 11, 2024, Getinge initiated 12 voluntary recalls for the Cardiosave IABP devices in the United States. Of these recalls, the FDA classified eight as Class I—the most severe recall type indicating a high risk of serious injury or death. Despite these recalls and corrective steps, such as updating instructions for use and providing new user actions, the FDA continues to receive concerning medical device reports (MDRs) related to these devices. Over the past year, there have been 2,964 MDRs associated with Cardiosave IABP devices, including 15 incidents resulting in serious injury or death. These reports highlight ongoing device failures, including issues with devices shutting down and blood entering the device, potentially causing helium emboli or exposure to patient blood.

In addition to the Cardiosave IABP devices, the FDA has raised alarms about the Cardiohelp system and HLS sets, which are used during cardiopulmonary bypass surgeries. Between January 1, 2023, and April 11, 2024, Getinge initiated eight voluntary recalls for these products, one of which was classified as a Class I recall. The FDA has received 246 MDRs related to the Cardiohelp system and HLS sets in the past year, with 33 reports of serious injury or death. Concerns about the sterility of the HLS sets have persisted, leading to the removal of other cardiopulmonary bypass devices from the market due to similar issues.

The FDA’s warnings underscore the critical need for healthcare providers to plan for alternative equipment to replace these problematic Getinge devices. While recognizing the limited availability of alternatives, the FDA advises providers to follow previous recommendations, stay informed about recalls, and report any adverse events or supply chain issues. The agency continues to work closely with Getinge and other manufacturers to address these problems and explore potential mitigation strategies.

Impact on Patients and Legal Recourse

Patients using these faulty cardiovascular devices face significant risks, including device shutdowns, exposure to bloodborne pathogens, and life-threatening complications. The reported injuries range from serious harm to fatalities, raising grave concerns about the reliability and safety of these medical devices.

Victims of these device failures may experience a variety of injuries, including cardiac complications, infections, and embolic events. These injuries often result in prolonged hospital stays, additional medical procedures, and substantial emotional and physical distress. The complexity and severity of these injuries necessitate a thorough understanding of patients’ legal rights and the avenues available for seeking compensation.

Victims injured by defective medical devices can file product liability lawsuits to seek damages for their injuries. These lawsuits typically fall into three categories: design defects, manufacturing defects, and failure to warn. In cases involving Getinge’s devices, plaintiffs might argue that the company failed to adequately address known issues and provide sufficient warnings about potential risks.

The lawsuit process begins with a thorough investigation to gather evidence supporting the claim. This includes medical records, reports of device malfunctions, and expert testimony. An experienced attorney is crucial in navigating this complex legal landscape, ensuring that all necessary documentation is collected and deadlines are met.

The damages recoverable in a product liability lawsuit can include medical expenses, lost wages, pain and suffering, and punitive damages. Given the potentially severe and long-lasting impact of injuries caused by defective medical devices, securing appropriate compensation is essential for covering the costs of ongoing medical care and restoring some measure of the victim’s quality of life.