Summary: Abbott is recalling its HeartMate II and 3 LVAS due to Extrinsic Outflow Graft Obstruction, which can impede device function and potentially lead to severe health risks or death. There have been 273 injuries and 14 deaths reported.

Key Takeaways:

  • The recall affects HeartMate II and 3 models.
  • Obstruction issue typically develops over two years.
  • Urgent action requested from healthcare providers to monitor for low flow alarms.

Abbott has issued an urgent recall for its HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS), commonly used devices that aid heart function. The recall follows the discovery of a serious issue termed Extrinsic Outflow Graft Obstruction (EOGO), which involves the accumulation of biological material that can severely impair the device’s effectiveness.

Understanding the Problem

EOGO occurs when biological material builds up in the space between the HeartMate Outflow Graft and the Outflow Graft Bend Relief or other components added during surgery. This obstruction can lead to decreased device performance, triggering alarms for low blood flow, and potentially jeopardizing the device’s ability to support the heart. Typically, this issue develops over a period of two years or more.

Health Risks and FDA Classification

The buildup can result in significant health problems, including serious injuries or even death. Reflecting its severity, the FDA has classified this as a Class I recall—the most critical type, indicating that the device could cause serious health consequences or fatalities. To date, there have been 273 reported injuries and 14 deaths linked to this complication.

HeartMate LVAS Description and Usage

The HeartMate II and HeartMate 3 devices are integral for patients with severe left ventricular heart failure, offering both short- and long-term support. These systems are vital in various scenarios, including as a bridge to heart transplantation, as support post-heart recovery, or as a permanent solution if a transplant is not feasible. Notably, the HeartMate 3 is also suitable for pediatric use.

Abbott’s Response and Customer Guidance

On February 19, 2024, Abbott proactively reached out to all affected customers with an Urgent Medical Device Correction Letter. This communication urged healthcare providers to complete and return an acknowledgment form and to remain vigilant for low flow alarms—a primary indicator of significant outflow graft obstruction. Abbott has committed to ongoing correspondence with new consignees to ensure all are informed of the necessary corrective measures until these issues are fully resolved.

Healthcare professionals are advised to monitor these alarms closely and consult the additional guidance provided by Abbott for diagnosing and addressing unresolved low flow problems linked to outflow graft obstruction.