Abbott Announces Recall of Heartmate Devices After Reports of Multiple Injuries and Deaths

Abbott’s recent recall of thousands of HeartMate II and HeartMate 3 left ventricular assist systems (LVAS) is a serious concern for cardiac support technology. This recall, affecting 13,883 units in the U.S. alone, was prompted by the accumulation of biological material leading to extrinsic outflow graft obstruction (EOGO), a flaw that compromises the device’s ability to effectively pump blood. This condition, which often develops over two or more years post-implantation, has already been associated with 273 reported injuries and 14 fatalities. The devices in question play a role in maintaining circulatory function by mechanically aiding the heart’s left ventricle, particularly in patients with severe heart failure awaiting a transplant or who are not eligible for one. With the HeartMate devices being the primary alternative after the withdrawal of Medtronic’s Heartware pump in June 2021, their malfunction poses a serious risk, emphasized by the FDA’s classification of this recall as Class I, indicating a situation where there is a reasonable probability of serious health consequences or death.

The root cause of the EOGO involves the interference by accumulated biological material between the HeartMate’s outflow graft and either the outflow graft bend relief or additional surgical components. This obstruction can trigger low blood flow alarms, signaling the potential for inadequate heart support. In response, Abbott has provided an urgent correction letter to healthcare professionals, highlighting the importance of monitoring for such alarms as a preliminary indicator of outflow obstruction. The letter details steps for diagnosing and managing unresolved low flow conditions that include imaging to rule out compression of the outflow graft, percutaneous interventions such as outflow graft stenting, surgical decompression, or ultimately, pump replacement if deemed necessary. This communication is important for clinicians to adjust treatment protocols and ensure patient safety effectively.

Further complicating the situation is the broad range of device distribution, with affected units dating back to April 2008. Abbott’s commitment to addressing the issue includes developing a design solution specifically for the HeartMate 3, aiming to minimize biodebris accumulation, pending regulatory approval. The discontinuation of HeartMate II complicates matters, highlighting a phased transition to improved device iterations that incorporate better design safeguards against such complications. The pivot reflects Abbott’s adaptive response to evolving technological requirements and regulatory standards, ensuring that newer models mitigate past design vulnerabilities. The timeline for implementing these changes remains important for current patients reliant on these devices.

The ongoing management of this recall is important for both Abbott and the healthcare providers using these devices. Abbott has set up a system for continued communication with all affected parties, ensuring they remain informed about the status of corrective measures and any new developments. Healthcare providers are instructed to use imaging and other diagnostic tools to assess the severity of any obstructions and to follow through with the recommended treatment protocols. The importance of these devices in patient care shows the need for strict oversight and prompt action in addressing any potentially life-threatening issues. The proactive steps taken by Abbott in recalling the affected devices and planning corrective measures are necessary for maintaining trust and ensuring the safety of patients reliant on these cardiac support systems.