Abbott (NYSE:ABT) began voluntarily recalling 204 Ellipse implantable cardioverter defibrillators in June to prevent the use of devices that may have a vulnerability in the electronic circuitry due to damaged wires, according to a recently-filed urgent field safety notice.
The company stressed that it has not received any product performance complaints or adverse patient events related to the problem.
Abbott’s Ellipse ICDs use aluminum wires to connect the high voltage components of the device, according to the company.
“During final manufacturing testing, two electrical failures were identified in a limited lot of manufactured devices due to damaged aluminum wires. Based on our investigation, we have decided to retrieve all non-implanted devices from this manufacturing lot and ensure you that have all requisite information to care for patients implanted with an impacted device,” Abbott explained.
The potential impact of this defect could be the inability to deliver high voltage therapy, Abbott said. Abbott advised doctors to explant and replace any devices that are related to the voluntary recall. The Ellipse ICD models involved are CD1411-36Q, CD2411-36Q and CD2411-36C.