Abbott (NYSE: ABT) issued the recall of the HeartMate II and HeartMate 3 LVAS due to an issue known as extrinsic outflow graft obstruction (EOGO). The issue happens when biological material builds up between the HeartMate outflow graft and the outflow graft bend relief, or additional components added during surgery.
The buildup in the systems can obstruct the device and make it less effective in helping the heart pump blood, according to the FDA warning letter. The LVAS can trigger alarms that indicate low blood flow and affect the device’s ability to help the heart correctly. The buildup of biological material typically occurs over two or more years.
FDA said this recall is a correction, not a product removal. There have been 273 reported injuries and 14 reports of death associated with this issue.
There are 13,883 devices connected to this recall with distribution dates starting April 21, 2008. Abbott initiated the recall on February 19, 2024. The full list of model numbers affected can be found on the FDA website here.
“Earlier this year, Abbott communicated to our customers about the potential for biological material to accumulate over time and disrupt the flow of blood through the outflow graft component of LVAD systems. While rates of outflow obstruction are low, Abbott worked to ensure physicians were aware of persistent low flow alarms that can provide an early warning to the potential issue as well as about diagnostic recommendations that can assess any potential obstruction. The company also reinforced options for treating an outflow obstruction. There are no products being returned as a result of this communication and patients whose LVADs are functioning normally without persistent low flow alarms have no reason for concern,” Abbott said in a statement to MassDevice.
What are HeartMate II and HeartMate 3 devices used for?
Abbott’s HeartMate II and HeartMate 3 LVAS help the heart pump blood when it is unable to do so effectively on its own.
The systems are used in short- and long-term support in adult patients with severe left ventricular heart failure. It can be used while waiting for a heart transplant, to help the heart recover or as a permanent implant when a transplant is not an option. HeartMate 3 is also indicated for use in pediatric patients.
HeartMate devices work by mimicking the pumping function of the heart’s left ventricle. The devices divert blood from the weakened left ventricle and propel it into the body’s main artery to help circulate blood throughout the body.
This is the second serious recall for HeartMate systems in recent months. In March, the FDA deemed Abbott’s recall of the HeartMate Touch Communication System as Class I. Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. The recall was also a correction, not a product removal. There were eight reported injuries and no deaths related to that recall.
Abbott’s remediation
The recall may affect healthcare professionals who may be using the LVAS and people receiving care through either of the LVAS.
Abbott sent all affected customers an urgent medical device correction letter in February and recommended they complete an acknowledgment form. The company will continue to send letters to new consignees until it has corrective measures in place, according to the FDA warning letter.
In the meantime, Abbott recommends users pay attention to low-flow alarms since they can be the first symptom of significant outflow obstruction. The company provided additional guidance on diagnosing unresolved low flow associated with the issue.
