FDA Class 1 Recall for Abbott's Ellipse Implantable Defibrillators

Patrice Wendling

August 06, 2019

Abbott is recalling Ellipse implantable cardioverter-defibrillators (ICDs) after reports that some devices have exposed aluminum wires. The US Food and Drug Administration (FDA) has classified this a class 1 recall, the most serious type, because potential use of the devices may cause serious injuries or death, the agency said in an August 5 notice.

Electrical failures in the ICD have occurred because of a "faulty manufacturing process causing some aluminum wires to be partially exposed," according to the agency. "ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor" and may be unable "to deliver high-voltage therapy."

In an urgent recall letter hand-delivered to customers on June 21, Abbott said it was initiating a global recall of Ellipse ICD models CD1411-36Q, CD2411-36Q, and CD2411-36C. Because there is no way to verify the "vulnerability status" of implanted devices, the company recommended explant and replacement.

The FDA notice says the recall affects all lots manufactured from April 5 to May 29 of Ellipse models CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, and CD2411-36Q. The devices were distributed from May 6 to June 14.

The recall affects 204 devices globally, and 31 had been implanted, according to Abbott spokesperson Justin Paquette.

"We have received no complaints related to this issue to date and the probability of patient harm is very low," he told theheart.org | Medscape Cardiology. "We have advised physicians so they can evaluate and determine next steps for patients who may have been implanted with an affected device."

Healthcare professionals and consumers can report adverse reactions or quality problems they experience using these devices to MedWatch. Customers with questions about patient management or this recall, can contact Abbott support at 1-800-727-7846 (select option 3), 8:30 AM to 5:30 PM (Central Time), Monday through Friday.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.


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