- Abbott is recalling 204 of its Ellipse implantable cardioverter defibrillators worldwide because some insulated aluminum wires may have become partially exposed.
- The damaged wires could prevent the defibrillators from delivering high voltage therapy, and there is no way to verify the vulnerability status for implanted devices, FDA said Monday. Abbott is recommending the devices be explanted and replaced.
- The agency said 108 of the devices were recalled in the United States, of which 31 had been implanted in patients. There have been no reports of harm to patients or adverse events, and no deaths reported, the agency said in the Class I recall.
Abbott acquired St. Jude Medical in 2017 for $25 billion to gain its portfolio of cardiac devices, including defibrillators and pacemakers to manage irregular heart rhythms.
The Ellipse recall comes a week after insurer Humana filed a lawsuit against Abbott alleging St. Jude allowed patients to be implanted with defibrillators it knew contained defective batteries and then devising a plan for the insurer to pay for removal surgery. Those devices were recalled in 2015.
A previous attempt by third parties to sue Abbott over the battery depletion issue was dismissed by the court due to a federal law involving preemption that protects medical device makers from product liability litigation.
In the Ellipse recall, the device’s damaged wires were the result of a faulty manufacturing process, FDA said. In a letter to physicians dated June 21, Abbott said two electrical failures were identified during final manufacturing testing in a limited lot of manufactured devices.
"Abbott recently voluntarily recalled a small number of ICD devices after we identified a potential issue that could impact the device’s ability to properly deliver therapy. We have received no complaints related to this issue to date and the probability of patient harm is very low," Abbott spokesman Justin Paquette said in an emailed statement.
The device is implanted under the skin in the upper chest with leads running to the heart. It is designed to provide an electrical shock to return an abnormally fast heartbeat to normal rhythm.
FDA said the company delivered an urgent medical device recall letter to customers. In the letter, the company said it would work with physicians to provide an Abbott replacement device.
The recall includes all lots manufactured between April 5 and May 29, 2019. The devices were distributed from May 6 to June 14, 2019. Model numbers affected are: CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q.