Abbott recalls Heartmate pump following 70 injuries, 2 deaths reported

Abbott recalled the Heartmate 3 left ventricular assist system due to blood leakage or air entering device seals. The FDA noted 81 incidents, including 70 injuries and two deaths, labeling it a Class I recall, but not requiring product removal.

This marks the third Heartmate-related recall since March, with prior issues involving potential biological material buildup and a communication system recall. The Heartmate pump supports blood circulation in severe left ventricular heart failure, serving as a bridge to transplant or aiding heart recovery.

Incidents of blood leakage or air entry occurred during implantation, affecting blood flow integrity and potentially causing complications like prolonged surgery or hemorrhage. Abbott assured patients of no immediate risk. Around 882 devices distributed since March 1, 2021, are affected in the U.S., with Abbott initiating the recall on March 13. Healthcare providers were advised to follow standard procedures if issues are suspected, with unused devices not to be returned.