FDA Posts Another Recall for Medtronic-HeartWare's HVAD Over Issues With Loose Power Connectors
The FDA today posted a Class I recall notice for select Medtronic-HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from functioning.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The agency identified issues with loose power connectors which could cause the rear portion of the pump’s driveline connector to become separated from the front portion of the connector.
A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
The agency identified issues with loose power connectors which could cause the rear portion of the pump’s driveline connector to become separated from the front portion of the connector.