MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

10 Biggest Medical Device Recalls of 2016—St. Jude Medical

Article-10 Biggest Medical Device Recalls of 2016—St. Jude Medical

St. Jude Medical

Device: The Fortify, Unify, and Assura Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators Click here for affected model numbers.

Recall reason: According to information on the FDA recall page, there were "reports of rapid battery failure caused by deposits of lithium . . . forming within the battery, and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replace, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death."

When recall was initiated: October 10, 2016

Number of U.S. units impacted: 251,346 units

For more information, visit the FDA Recall page.


[Image courtesy of ST. JUDE MEDICAL]

Take the Medical Innovation Tours during the BIOMEDevice San Jose Conference and Expo, December 7-8.
Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.