Class I Recall of Abbott (Formerly St. Jude Medical Inc.), Ellipse Implantable Cardioverter Defibrillators

Published: 08/06/2019

  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor. The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to deter

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