Framingham Device Firm To Repair Units
Framingham-based medical device firm HeartWare International Inc. said it has recalled and will repair or replace malfunctioning controllers on its Left Ventricular Assist System heart pumps.
The controllers include audible alarms, along with visual displays visible to both patients and doctors. The alarms are tested regularly. Some of the alarms shipped last year included new waterproofing technology, but developed excess air vacuum during air transportation, which caused lower alarm volume in some units, the company said.
The company said it is doing air pressure simulation testing on the devices in order to screen out "susceptible units."
Beginning last December, the company began adding a small vent to the controllers to prevent excess air vacuum.
Only one occurrence of decreased volume has been reported in the United States, where HeartWare is awaiting approval of the LVAS by the U.S. Food and Drug Administration.
The company also sells the devices in Europe and Australia.
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