FDAnews Device Daily Bulletin

Abbott Warns of Problems With HeartMate 3 Pump

June 28, 2017

Abbott warned that its HeartMate 3 device may be susceptible to communication errors.

The company noted the potential for communication errors between the device’s system controller and the left ventricular assist system pump and said it has updated manufacturing processes and specifications to prevent the errors in future product lots.

Abbott said it received 11 reports of communication line faults out of 850 implanted devices. In eight of those cases, only one of the device’s two communication lines went down, according to the company. In one report, however, both communication lines appeared to be permanently affected.

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