Abbott’s latest HeartMate troubles are related to two deaths as well.
The company initiated the recall of its HeartMate 3 left ventricular assist system implant kit on March 13. This recall — a correction, not a product removal — follows last month’s Class I recall for some HeartMate II and HeartMate 3 systems.
HeartMate 3 helps the heart pump blood when it fails to pump blood effectively on its own. The 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.
Abbott recalled the system after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. In all reported cases, users saw the issue during the implantation of the device.
Blood leakage or air entering the LVAD from this location will impact the integrity of blood flow. It could lead to longer-than-expected surgery, bleeding (hemorrhage), right heart failure or air embolism. The FDA’s Class I designation means use of the device may cause serious injury or death.
Abbott reported 81 incidents, including 71 injuries and two deaths related to the issue. The recall affects 882 devices distributed between March 1, 2021, to present.
The company issued an urgent medical device correction notification on March 20. It instructed customers to not return unused product as this recall is not a product removal. If blood leak or air entrainment is suspected or observed, they should follow standard surgical processes and the existing instructions for use.
Statement from Abbott on the HeartMate 3 recall
An Abbott spokesperson shared the following statement with MassDevice via email:
In March, Abbott notified physician implanters of HeartMate 3 about reports the company has received related to leaking that can occur during an LVAD implant if the device’s apical cuff and inflow cannula aren’t sealed correctly, allowing blood or air to pass between the heart and the device. Importantly, no products are being removed from the market and patients living with an LVAD are at no risk related to this issue.
While rates of serious adverse events related to this issue are extremely low, Abbott is working with physicians to reiterate surgical instructions that can stop blood and air leakage prior to completing an LVAD implant. We are also developing a change in the seal interface for the HeartMate 3 that will help address this issue.
Another blow against LVAD adoption
The recent serious recalls could create headwinds when it comes to the adoption of LVADs, which has proved challenging.
Abbott’s research has shown that its HeartMate 3 pump can extend the lives of advanced heart patients by at least five years. However, Abbott estimates the U.S. has 15,000 advanced heart failure patients who are managed with inotropic therapies alone; they have a projected median lifespan under a year.
Abbott’s HeartMate pumps are currently the only LVADs on the U.S. market. Medtronic stopped selling its HVAD in June 2021 due to mounting issues with the platform.
Editor-in-chief Chris Newmarker contributed to this report.
