Medtronic is recalling the HeartWare HVAD System to provide updated Instructions for Use and Patient Manual due to safety issues.
The HeartWare Ventricular Assist Device (HVAD) System is used as a bridge to heart transplants in patients who are at risk of death from end-stage left ventricular heart failure, or as a final (“destination”) therapy for patients where new transplants are not planned.
Medtronic is recalling the HeartWare HVAD System to provide updated Instructions for Use and an updated Patient Manual due to safety issues with carrying cases, driveline cover orientation, and controller power-up sequence. If using the HVAD system and the carrying case breaks and the driveline pulls out of the controller as it drops, or the driveline disconnects from backwards driveline cover orientation; or a controller exchange is performed unnecessarily due to confusion of start-up behavior as a “red alarm” battery failure, this may cause serious patient harm, including death.
The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. There has been 1 death and 64 injuries reported to the FDA for these issues.
Food and Drug Administration (FDA). Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues. May 12, 2021. Available at: click here. Accessed May 12, 2021.