Twelve Deaths Cause a Fourth Recall For Medtronic’s HeartWare
WASHINGTON, DC – The US Food and Drug Administration announced that Medtronic has been received another high-risk Class I recall designation from the FDA. The Class I recall involves its HeartWare Ventricular Assist Device (HVAD) cables and controller ports. This is the second Class I recall issued for Medtronic’s HeartWare device in approximately six weeks.
This Class I recall involves the “risk of wear and tear of the connector plugs (power sources, data cable, and alarm adapter), causing damage to the controller port metal pins (for example, bent pins) for Medtronic’s HeartWare Ventricular Assist Device (HVAD) battery cables, data cables, adapter cables and controller 2.0 ports.”
According to the report, those components come with the HeartWare HVAD System. The system is an intrapericardial centrifugal left-ventricular assist device (LVAD) and is used to treat patients with advanced heart-failure.
The FDA stated that the damaged controller ports can prevent power cables and data cables from connecting with the controller. This leads to a partial or full stop of the pump. When the pump stops, this can cause significant harm to the patient, including death, heart attacks, hospitalization, and loss of consciousness.
So far, there have been eight report of injury and twelve fatalities linked to the affected HeartWare HVAD Systems. A total of 855 complaints have been made against the device, which was manufactured and distributed beginning in 2006. Over 106,000 devices are being recalled.
Medtronic issued an urgent safety notice to customers starting on February 26, 2021. The notice alerted the consumer to the life-threatening problem and provided guidance.
According to the news report, HeartWare’s other Class I recall was initiated on March 1st. That recall dealt with the pump implant kits. The FDA stated that the problem was part of the HeartWare HVAD System, but the reason for the recall concerned the device’s failing to “initially start, restart or have a delay i
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