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HeartWare HVAD System by Medtronic: Class I Recall – Due to Unintended Intermittent Electrical Disconnection between the Power Source and the Controller

Interruptions to the electrical connection could cause a pump stop. A pump stop could cause patient harm such as exacerbation of heart failure symptoms, or symptoms such as mild weakness, loss of consciousness, or death.

Original source: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609599.htm

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