Thursday, April 15, 2021

Medtronic Inc recalls HeartWare HVAD Cables and Controller Ports

This Recall is Due to Risk of Damage to Controller Ports

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US Food and Drug Administration

Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports

Medtronic Inc is recalling the HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports due to risk of damage to controller ports. This may prevent power cables and data cables from being connected to the controller and lead to a full or partial stop of the pump. If this happens, this may lead to serious adverse events, including loss of consciousness, hospitalization, heart attack, or death.

The FDA has identified this as a Class I recall, the most serious type of recall.

Read the Recall Notice


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