Medtronic, Inc. is recalling the Instructions for Use and Patient Manual that accompany the HeartWare Ventricular Assist Device (HVAD) System in order to provide updated information due to safety issues. The Food and Drug Administration (FDA) has designated this a Class I recall, the most serious type.
The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation, myocardial recovery, or as destination therapy in patients for whom subsequent transplantation is not planned. The recall is prompted by safety issues related to the carrying case, driveline cover orientation, and controller power-up sequence.
The following updates will be made to the Instructions for Use and Patient Manual related to these components:
- Carrying Case: Information about the lifespan for the carrying cases, as well as how to safely clean and wear the convertible patient pack.
- Driveline Cover Orientation: Information on keeping the driveline cover on when disconnecting and reconnecting the driveline during a controller exchange.
- Controller Power-Up Sequence: Information to clarify that the expected power-up sequence causes the alarm indicator LEDs and both sets of battery LEDS to turn red for 2.5 seconds while the controller LCD displays the power-on message.
Serious harm may occur if the carrying case breaks and the driveline pulls out of the controller as it drops; if the driveline disconnects from backwards driveline cover orientation; or if a controller exchange is performed unnecessarily due to confusion of start-up behavior as a red alarm battery failure. At this time, 1 death and 64 injuries related to these HVAD system issues have been reported to the FDA.
Medtronic has issued an urgent notice to all affected customers regarding the forthcoming labeling updates. These updated steps should be reviewed and shared with patients and organizations where potentially affected patients may have been transferred.
Additional information about the recall can be found here.
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. [press release]. Silver Spring, MD: US Food and Drug Administration; May 12, 2021.