Regulatory Battery and Shutdown Issues Lead to Another Class 1...

Battery and Shutdown Issues Lead to Another Class 1 Warning for Getinge’s Heart Pump


In recent months, Getinge’s intra-aortic balloon pumps have encountered several setbacks, raising concerns about patient safety and the need for reliable medical devices. These challenges have resulted in multiple recalls and suspensions, forcing the healthcare provider to halt sales in certain cases.

The most recent development involves the U.S. Food and Drug Administration (FDA) issuing a Class I recall for Getinge’s intra-aortic balloon pumps due to electrical issues. These pumps, designed to regulate the heart’s rhythm by inflating and deflating intra-aortic balloons, have been found to be vulnerable to abrupt shutdowns caused by failures in power management or solenoid boards. Such sudden halts in the mechanism could lead to severe consequences, including destabilized blood pressure, organ injuries, inadequate blood supply, and potentially fatal outcomes.

Additionally, a flaw in the device’s design has been identified, resulting in the loss of the pumps’ ability to charge their own batteries. In situations where the pumps are disconnected from AC power, this flaw could result in a complete loss of power, interrupting critical heart-pumping therapy. Although the devices are designed to emit a low battery alarm before shutting down, the potential risks remain a cause for concern.

Over 9,000 devices of both Cardiosave Hybrid and Cardiosave Rescue models, which have been distributed globally, have been affected by the recalls. Approximately half of these devices were distributed in the United States. Despite 26 complaints related to the shutdown issue, no patient injuries or deaths have been reported thus far.

In response to these challenges, Getinge has recommended that healthcare providers have alternative pump options available to ensure uninterrupted patient therapy. In cases where intra-aortic balloon pumps are inaccessible, other technologies such as ventricular assist devices and extracorporeal membrane oxygenation machines should be considered for hemodynamic support.

The recent recalls are not the first instances of trouble faced by Getinge’s intra-aortic balloon pumps. Earlier this year, the devices were recalled due to tears or damage to the balloons, potentially causing blood to flow into the mechanism and creating emboli that could block blood flow. This issue was linked to 134 complaints over a four-year period, with adverse patient events, including serious injuries and even a fatality, reported.

These challenges have extended beyond the United States, as the devices also experienced a suspension of their CE mark in Europe by the German notified body TÜV SÜD. This suspension temporarily prevented the pumps from being sold in Europe for three months. Getinge is committed to addressing the issues identified in risk management, post-market surveillance, and vigilance to regain regulatory compliance.

The multiple FDA Class I recalls and the CE mark suspension plaguing Getinge’s intra-aortic balloon pumps have raised concerns about patient safety. The recalls were triggered by electrical failures and design flaws, risking abrupt shutdowns and interruptions in heart-pumping therapy. While no injuries or deaths have been reported, thousands of devices around the world have been affected.

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