The FDA recently announced that the HeartWare HVAD system was being recalled by medical device manufacturer MedTronic over concerns of battery failure. The recall marks the second time the device has been recalled, with both occurrences falling under Class I status. The Class I recall is the FDA’s most severe recall classification and is reserved for instances where the continued use of the recalled item could cause severe injury or death.
This latest HeartWare HVAD recall stems from issues with the device’s batteries. According to a release issued on the FDA’s website, a single lot of Medtronic HeartWare HVAD systems has been recalled “due to welding defects that allow separation of the two cell battery packs used to power the system.” The defect can cause the battery to fail suddenly. And while the device may trigger an alarm to alert the user that the device has failed, the battery will continue to operate in a fail state.
One death has already been attributed to the defect, although alleged failures in HeartWare HVAD devices have been implicated in thousands of deaths to date. The first recall, issued in 2016, was triggered when it was discovered that the HVAD’s external control units were susceptible to moisture. The moisture could make alarms harder to detect or lead to a complete failure of the unit, essentially cutting power to the device that is the only thing circulating a patient’s blood after their heart has failed.
Since then, additional faults have been found in the HVAD system, including the possibility of pump thrombosis and short circuits of the device within patients’ chests. Deaths from these events have been horrific with some loved ones being forced to watch as the patient collapses to the ground and vomits blood. An autopsy on one HVAD patient showed charring on their heart from the short circuit that killed them.
