The U.S. Food and Drug Administration (FDA) has issued a Class I recall for the Thoratec HeartMate II implantable heart pumps over a controller issue that the FDA said was associated four patient deaths and five serious injuries.
Thoratec initiated the recall early last month for devices distributed from August 2012 through this year, according to the FDA notice. The HeartMate II LVAS (left ventricular assist system) implantable pump helps circulate blood when the patient’s heart is too weak to circulate blood on its own. The injuries and deaths occurred when patients attempted to swap the HeartMate II LVAS devices from an older controller to the Pocket System Controller, MassDevice.com reports.
A Class I recall is the FDA’s most serious recall classification and involves situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death.
The recalled devices are
• HeartMate II LVAS Implant Kit with Pocket Controller (catalog numbers 106015 and 106016)
• HeartMate II LVAS Pocket System Controller (catalog numbers 106762 and 106017)
• HeartMate II LVAD Pump and Pocket Controller Kit (catalog number 107801)
• Pocket System Controller removed from packaging (catalog number 105109)
The injuries and deaths occurred because of difficulty in changing from the primary system controller to a back-up system controller. Patients who were switched from the EPC System Controller to the Pocket System Controller when it became available may not have received intensive training on connecting the new controller. The design differences between the EPC System Controller and the Pocket System Controller require a different approach to how the device is connected, the FDA notice explains. If the controller is not properly connected, the device cannot function.
Thoratec advises that all patients using the Pocket System Controller and their caregivers should be retrained on the use of the device and should be provided with updated Patient Handbook information. Thoratec will update labeling and training materials for the device, according to the FDA.
Individuals with questions about the recall may contact Thoratec Corporation at 800.528.2577 or 925.847.8600, 7 days a week, 8 a.m. to 5 p.m., Pacific Time.