The Minneapolis Star Tribune reports that “at least 26 patients in advanced heart failure have died after replacing the controller for an Abbott Laboratories blood pump while out of the hospital.” Medtronic is recalling 28,882 of its HeartMate II controllers “after reports of 70 incidents in which the life-preserving device malfunctioned after a patient changed out the controller at home.” The FDA has classified the recall as Class I, saying, “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 … changeover places them at risk of serious injury or death.”
Qmed reports that “although no devices must be returned, Abbott told providers that existing patients will receive updated device software and alarm guides for their primary and backup controllers.” New patients on the device “will receive updated hardware and software, including a fully integrated controller with new alignment markings and a new driveline.”
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