Abbott (NYSE:ABT) is recalling nearly 29,000 controllers for the HeartMate II implantable heart pump made by its Thoratec subsidiary 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.
“All of the deaths occurred when patients attempted to exchange controllers while away from the hospital,” the federal safety watchdog said yesterday. “Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.”
Abbott spokesperson Laurel Hood added: “No products are being retrieved in this case; rather, the focus is on communication to physicians so they can ensure their patients have their controller exchange completed in a clinical setting. We have also updated our software and controller alerts to help patients connect with their physician’s office when they need to have their controller exchanged.”
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