The U.S. Food and Drug Administration (FDA) has announced that Abbott – formerly St. Jude Medical Inc. – is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs). The recall is due to exposed aluminum wires that may prevent defibrillation therapy. According to the FDA, "there is currently no available method or procedure to determine which of these devices have this issue prior to failure."

To date, Abbott has not yet learned of any related reports of this failure occurring in any affected implanted devices. Health care professionals are encouraged to check device model and serial numbers to identify the impacted patients, and to work with Abbott to receive the appropriate replacement to move forward with device explant.

Read the FDA press release here.

Keywords: ACC Advocacy, Defibrillators, Implantable, Aluminum, United States Food and Drug Administration, Electric Countershock, Mental Recall

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