August 5, 2019

FDA: Class I recall of Ellipse Implantable Cardioverter Defibrillators

By: Judy Mathias
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Editor’s Note

The Food & Drug Administration on August 5 identified the recall by Abbott (formerly St Jude Medical Inc) of its Ellipse Implantable Cardioverter Defibrillators as Class I, the most serious.

The recall was initiated because electrical failures have been identified that are due to a faulty manufacturing process causing some aluminum wires to be partially exposed. The exposed aluminum wires may prevent high voltage defibrillation therapy.

Distribution dates of the defibrillators are May 6, 2019, to June 14, 2019.

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