Thoratec (NSDQ:THOR) today issued a warning to users of its HeartMate II left ventricular assist system over battery expiration dates in its pocket system controller, which the company specified does not affect normal heart pump function.
The backup batteries have 36-month expiration dates, the Pleasanton, Calif.-based company said, and will display an advisory alarm at 12:00 a.m. on the 1st day after expiration, indicated by a yellow wrench symbol.
Reports came in from several hospitals with patients who received the advisory alarm due to non-replacement of the battery, Thoratec said. Some of the patients attempted to switch their batteries from their primary to a backup system controller, which resulted in 3 cases where patients were unable to reconnect the pump.
Of the 3 who failed to reconnect the pump in a timely manner, 2 individuals died and 1 was seriously injured, Thoratec said.
Thoratec advised that devices with serial numbers starting with “PC” who have had the pump for over 2 years should contact their doctors immediately to check expiration dates.
The company advised patients who receive the alarm to contact their hospital for instructions, and not attempt to replace the system controller unless instructed to.
Thoratec said they have advised the FDA on the issue.