On May 22, 2018, the FDA announced a Class 1 Recall—the most serious kind—of nearly 5,000 HeartMate 3™ Left Ventricular Assist Systems. These medical devices are used for patients with end-stage left ventricular heart failure to assist the heart in pumping blood to the rest of the body.
The system has a pump that is implanted in the space around the heart to help the heart pump blood throughout the body, along with an outflow graft that connects the pump to the aorta.
According to Abbott, the device manufacturer, a malfunction in the device’s assembly can reduce or stop the device’s pump flow and prevent it from working as it should, which can cause blood clots and death. Patients are advised to contact their physicians immediately about the issue, particularly if their device develops a persistent “low-flow” alarm which may signal that the device is not working properly.
Abbott Drags Feet on Recalling HeartMate 3™ Left Ventricular Assist System
On April 5, 2018, Abbott sent an “important medical device advisory” to physicians, warning them of the issue. The company reported that it had received 32 reports of “outflow graft twist occlusions” (blockages) occurring in the devices leading to a persistent low-flow alarm. “Outflow graft twists can result in serious adverse events such as hemodynamic compromise, thrombus, and death”.
Abbott advised physicians that there were many possible reasons that the device’s alarm might persist, including high blood pressure and heart failure. The company also gave guidelines for implanting the device, and suggested that if the outflow graft did twist, doctors should surgically repair it to prevent further kinking or blockages. The manufacturer did not offer to replace the unit.
On May 4, 2018, Abbott sent a follow-up letter to physicians stating they were not recalling the devices, but were implementing a “field corrective action” to address the issue. The company reported that it had received 32 reports of outflow graft twisting and three reported deaths that could have resulted from the issue, and reiterated the advice provided in the previous letter.
Abbott Sends Urgent Medical Device Recall
On May 21, 2018, Abbott sent an Urgent Medical Device Recall to physicians, again alerting them to the problem with the device and providing instructions for managing patients receiving the device and those with the device already implanted.
Among the instructions, Abbott advised doctors to:
- Follow-up with patients regularly as recommended by the American Society of Echocardiography.
- Use recommended imaging techniques to find out if the outflow graft is twisted or obstructed.
- Note that a decrease in blood flow over time could be an indicator of an outflow graft twist obstruction.
- Be aware that a persistent low-flow alarm could indicate an outflow graft twist occlusion.
- If repair is needed, reattach the outflow graft bend relief to its original state, or repair it otherwise to prevent bending and occlusion.
If you or your loved one has been implanted with a HeartMate 3™ Left Ventricular Assist Systems and has experienced any potential issues or has a device that has developed a persistent “low-flow” alarm, it is important that you contact your doctor as soon as possible. Abbott has not offered to replace the devices, and has only informed doctors and patients about the potential for device malfunction.
Exclusively focused on representing plaintiffs—especially in mass tort litigation—Roopal Luhana prides herself on providing unsurpassed professional legal services in pursuit of the specific goals of her clients and their families. While she handles complex cases nationwide on behalf of consumers, Ms. Luhana resides with her family in Brooklyn, New York.