The company began the recall in June, citing damaged wires in 204 Ellipse pacemakers distributed globally.
Today’s FDA announcement said that a faulty manufacturing process had left the Ellipse devices with partially exposed aluminum wires. That lack of insulation can short out the capacitor, leaving the ICD to possibly fail to deliver high-voltage therapy, the agency said. There is no available method or procedure to determine which of these devices have this issue prior to failure, according to the FDA.
The June urgent field safety notice listed Ellipse devices with model numbers CD1411-36Q, CD2411-36Q and CD2411-36C. That list has been expanded to include model numbers CD1377-36C, CD1377-36QC and, CD2377-36QC. The company is recalling 108 devices in the U.S., manufactured between April 5, 2019, and May 29, 2019.
No patient injuries or deaths have been reported from among the 31 devices that have been implanted, according to the FDA. Abbott is recommending explanting the devices.