The FDA issued a recall of Abbott’s Ellipse implantable cardioverter defibrillators (ICDs) as exposed aluminum wires may fail in providing the necessary defibrillation therapy.
About The Recall
The ICDs aluminum wires are not fully insulated and may short out, thus harming the patient as opposed to helping.
The recall of these ICDs are designated as the most critical, a Class I, recall. This means that the product can result in serious injury and/or death. The recall affects 108 devices in the U.S., alone.
Ellipse ICDs are implanted under the skin in the chest. The connecting wires are then planted in the heart. Patients are given the ICDs to reconcile a heartbeat that is too slow, too fast, and to treat heart failure.
What you need to know: Model numbers covered by the recall are CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, and CD2411-36Q.
Abbott advises patients affected by the recall to get their device replaced with a device that they will provide free of charge. To date, there are no reports of harm or illness related to faulty wires.
The FDA recall on Abbott devices comes just after insurer Humana filed a lawsuit against St. Jude Medical— a newly acquired Abbott company— for hiding issues with pacemakers and other cardiac devices between 2011 and 2015.
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About the Author: Aisha K. Staggers is a writer, lecturer, political analyst and literary agent. She appears weekly for “Staggers’ State of Things” on the Dr. Vibe Show. Her work has been published by Paper Magazine, AfroPunk, The Spool, GREY Journal, MTV News, HuffPost, Blavity, Atlanta Blackstar, For Harriet, New York Review of Books and a host of other first-run publications and syndicated outlets. Find her on Twitter @AishaStaggers. For more of her work, check out her page here!