> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# St. Jude Recalls 250,000 Defibrillators
- URL: https://www.fdaweb.com/st-jude-recalls-250-000-defibrillators/
- Published: 2016-10-25T12:00:00.000Z
- Updated: 2026-09-14T21:42:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137167

St. Jude Medical has recalled certain models of its Fortify, Unify, and Assura implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) due to reports of rapid battery failure caused by deposits of lithium (lithium clusters) 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 replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death,” a [recall notice ](http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526317.htm?ref=fdaweb.com)says. Over 250,000 devices are affected and they were manufactured between 1/2010 to 5/2015.