It is yet another Class I recall for the device, which Medtronic stopped selling more than a year ago as problems mounted. The medtech giant’s move ceded the LVAD space to Abbott.
Medtronic recalled the HeartWare Ventricular Assist Device (HVAD) batteries (model number 1650DE) because they may experience electrical faults that cause them to fail unexpectedly. Such an occurrence means the batteries may be unable to power the controller, unable to accept a charge from the battery charger or appear to remain charged when in use.
If the battery fails and the patient is unable to replace the failed battery with a charged, working battery or with AC or DC power, the HVAD may stop working, leading to serious injury or death, according to the FDA notice.
The medtech giant has recalled 23,372 devices, distributed from Jan. 1, 2009, to the present day, after initiating the recall on June 28, 2022. To date, Medtronic has reported 1,159 complaints, six injuries and one death related to the issue.
Medtronic’s HVAD system helps the heart continue to pump blood to the rest of the body as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned.
As part of the company’s June 28 urgent medical device correction letter regarding the issue — as well as a previous battery recall — telling customers to address the battery electrical fault by keeping two sources of power connected to their controller and have fully charged spare batteries available at all times.
Users should also acknowledge and report alarms, follow instructions for use for proper power source management. They should also be vigilant if battery indicator lights don’t decrease over time while the battery is in use.
The recall is the latest hurdle for Medtronic’s HVAD, which last year saw its instructions for use and patient manual recalled due to risks from dropping the case, incorrect installation and misinterpretation of an alarm signal. That recall included 130,716 devices in the U.S. distributed from March 2006 to the present (Feb. 26, 2021), with one death and 64 injuries reported.
Medtronic’s Feb. 26 recall also covered problems associated with HeartWare controller ports that the FDA announced in April 2021. The agency reported 12 deaths, 855 complaints and eight reports of injuries — figures that the company disputed.
In December 2020, Medtronic recalled its HeartWare HVAD pump implant kit because the device may fail to start, restart, or delay restarting after the pump was stopped. The FDA confirmed that recall in March, reporting with it two related deaths.
