Following at least a dozen deaths, Federal health officials have issued yet another recall involving Medtronic HeartWare HVAD cardiac devices, indicating the controller and power cabling may be prone to unexpected failure and cause the devices to stop functioning.
The FDA announced the Medtronic Heartware HVAD recall on April 15, after the manufacturer received more than 800 complaints involving problems with failing electrical components, including at least 12 deaths which may have resulted from the problem.
The HeartWare Ventricular Assist Device (HVAD) is designed to help pump blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure. These patients use the pump while waiting for a heart transplant. The system includes a pump implanted in the space around the heart and a controller regulating the speed and function of the pump. It is designed to be used either in a hospital setting or during patient transport.
According to the recall notice, the recalled Medtronic HVAD devices are equipped with battery cables, data cables, adapter cables and controller 2.0 ports, which may be at risk of wear and tear at the connector plugs. In the event of a bad connector plug connection, the Controller port metal pins could become damaged, causing a partial or full stop of the pump.
Medtronic sent an Urgent Medical Device Notice to all affected customers on February 26, advising healthcare providers to immediately inspect the Heartware HVAD components for scratches on the plug face, surface irregularity, dents, chips or cracks and for dents chips or cracks in the power and data cabling. To date, Medtronic has become aware of 855 complaints in which the cabling and controllers unexpectedly failed.
The recall affects Medtronic HeartWare HVAD battery cables, data cables, adapter cables, and controller 2.0 ports manufactured from March 7, 2006 to the present ,and distributed from October 9, 2006 to the present. Product numbers for the affected Medtronic HVAD Controller AC Adapters include 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. The recall also affects Medtronic HVAD Controller DC Adapters with a product number of 1440; batteries with a product number of 1650DE; alarm adapters with a product number of 1450; monitor data cables with a 1575 product number; and controllers with product numbers 1400, 1401, 1403, 1407, and 1420.
On April 15, the FDA designated the recall as Class I, which is the most serious recall classification, suggesting continued use of the HeartWare implants pose a risk of serious adverse events or death.
Electrical malfunctions or stopping the pump may lead to serious adverse health consequences, including death of the user, the FDA warns. Patients and healthcare providers are being encouraged to report any adverse event arising from the use of the HeartWare devices to the FDA’s MedWatch Adverse Event Reporting Program.
Medtronic Heartware History of Recalls
HeartWare devices have a long history of manufacturing and design defects and have been the subject of numerous recalls. Just last month, the FDA announced the Medtronic HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit recall following device power failure issues that resulted in two patient deaths and dozens of complaints.
In May 2020, Medtronic issued 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.
In June 2018, Medtronic issued a HeartWare HVAD power failure 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.
Another recall was issued for the HeartWare device in August 2015. The recall was issued after reports of bleeds, blood clot complications, strokes and other injuries were linked to the devices.
HeartWare reported they were conducting clinical trials to better evaluate the safety of their devices, yet continue to experience problems.