Medtronic HVAD Pump Recall Issued After Deaths, Life-Threatening Injuries Reported

Following a number of reports involving problems which resulted in serious injuries or deaths, Medtronic is recalling certain HeartWare pump imlant kits, due to a risk the devices may fail to turn on or restart.

The FDA announced the Medtronic HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit recall on March 1, following at least 19 complaints of the devices failing to initially start, restart, or have a delay in restarting after the pump was stopped, which may have resulted in at least two deaths.

The recalled Medtronic Pump Implant devices are part of the HVAD system, which is designed to assist the heart in delivering blood to the rest of an individual’s body. The devices are typically used as a bridge to cardiac transplant for patients at risk of left ventricular heart failure. It is used on patients both in the hospital and out of the facility.

Medtronic first issued an Urgent Medical Device Communication Letter on December 18, 2020, warning the devices could experience a power failure during pre-implant testing, during the implant procedure, or in a variety of post-implant situations. These HVAD pump problems could result in serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.

The warning instructed health care providers and staff not to disconnect the driveline from the controller and to never disconnect the device from both the battery and AC or DC power sources.

Since the initial warning, the FDA has become aware of 29 total complaints in which the devices failed to power on or reboot correctly, resulting in prolonged or failure to treat patients in life threatening scenarios.

To date, 19 serious injuries, eight cases of patients suffering life-threatening injuries who ultimately recovered without long term effects, and two deaths have been reported in association with the problem.

The recall includes HVAD Pump Implant Kits for the HeartWare HVAD System manufactured by Medtronic, marked model number PUMP 1103, PUMP 1104, and PUMP 1104JP. The affected pump kits are marked with lot numbers 8721869-001-01, 8722375-001-01, or 8722375-002-02 and were distributed to for sale to medical facilities across the nation from October 23, 2017 to April 30, 2020.

Medtronic is instructing healthcare professionals to inform patients with implanted pump kits to immediately contact their Ventricular Assist Device coordinator to schedule a controller exchange before the internal controller battery reaches its two year end of life timeframe.

The recall notice warns that all controller exchanges should be performed under clinical supervision and in an environment with immediate availability to put patients on hemodynamic support to prevent serious injuries or death.

The FDA has classified this recall as a Class I recall, the most serious recall classification. This means the agency believes the problem can result in serious injury or death.

Medtronic has faced several HeartWare problems in recent years due to power failure and hardware defects.

In June 2018, Medtronic issued a HeartWare HVAD recall impacting more than 16,000 units that had been implanted in patients as of May 22, 2020. The recall was initiated after Medtronic discovered the electrical connection between the system’s power source, such as the battery, AC adapter, or DC adapter, and the HVAD controller could be interrupted, potentially causing the pump to stop working, resulting in an exacerbation of heart failure symptoms, including weakness, dizziness, anxiety, nausea, loss of consciousness or death.

In May 2020, Medtronic issued yet another HeartWare HVAD Class I recall following nearly 100 reports of problems where the strain relief screw broke and outflow graft tore while preparing the device for implant. The recall warned the design defect placed patients at risk of suffering serious injuries, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, and the need for additional medical procedures or death.