Abbott to update software, guides on HeartMate II system controllers

Abbott (NYSE:ABT) recently said it will be updating its alert guides, software and adding controller alignment markers for its Thoratec subsidiary’s HeartMate II system controller as it looks to clear up issues patients have had while trying to exchange the controllers in emergency situations.

The Abbott Park, Ill.-based company said that its update will include new labeling and alarm guides, provided by an Abbott representative, a software upgrade to simplify alarm messaging and enhanced connector alignment markings to provide clearer guidance in aligning connectors during insertion or removal.

Patients using the HeartMate II LVAS can expect to receive software updates, labeling and alarm guides from their VAD coordinator, and that an Abbott representative would be in contact to assist in scheduling the updates, according to an urgent medical device correction notice.

Earlier this year, Abbott said it would recall nearly 29,000 controllers for the HeartMate II implantable heart pump after 26 patients died trying to change out the controllers on their own.

The March 29 recall of 28,882 controllers for the HeartMate II left ventricular assist device follows 70 reports of “incidents in which the controller has malfunctioned after an exchange,” including 19 injuries and the 26 deaths, according to the FDA.

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