FDA: Class I Recall for Ellipse ICD Due to Faulty Wires

(UPDATED) The Ellipse implantable cardioverter-defibrillator (ICD) is being recalled by its manufacturer following reports of exposed aluminum wires, potentially preventing the device from delivering high-voltage therapy. Abbott says it “hand delivered” urgent medical device recall letters in late June recommending that centers check model and serial numbers to identify impacted patients and then move ahead with device explant and replacement.

Today, the US Food and Drug Administration identified the action as a Class I recall, meaning use of the defective devices may cause serious injuries or death.

According to the FDA, electrical failures were identified in this model of ICD due to damaged wires, which may not be completely insulated. Moreover, there is no way of verifying “vulnerability status” for implanted devices, hence the need for explant and replacement.

An Abbott spokesperson told TCTMD that the recall is limited to a total of 204 devices and said the company is not aware of any failures in any of the 31 devices implanted in the United States so far. “The complaints and [medical device reports] available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator,” the FDA recall notice states, adding that none of those complaints or reports “indicate that any patient harm or adverse events have occurred, and no deaths have been reported.”

“We have received no complaints related to this issue to date and the probability of patient harm is very low,” Abbott's Justin Paquette told TCTMD in an email.

Customers are asked to contact the manufacturer with questions or to discuss replacement devices.

The ICD was originally manufactured by St. Jude Medical, which was acquired by Abbott in 2017.