St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion
Fortify, Unify, and Assura (including Quadra) Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
Model/Item Numbers: See “Full List of Affected Devices”
Manufacturing Dates: January 2010 to May 2015
Distribution Dates: February 2010 to October 2016
Devices Recalled in the U.S.: 175,624 Nationwide
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
Images of a Fortify Assura VR ICD, and a Quadra Assura CRT-D
This recall notice updates FDA’s October 2016 recall notice to include information about the Battery Performance Alert (BPA), a new battery performance management tool that St. Jude Medical notified customers about on August 28, 2017.
On August 28, 2017, St. Jude Medical notified physicians of the availability of Battery Performance Alert (BPA), a new battery performance management tool that detects and notifies physicians of abnormal battery performance that may lead to premature battery depletion in Implantable Cardioverter Defibrillators.
If a BPA is triggered for a patient’s device, the patient’s physician will be notified through the device programmer and/or the Merlin@home monitoring system. St. Jude Medical recommends immediate device explant and replacement.
If a BPA is not triggered, St. Jude Medical recommends that physicians follow patient management recommendations included in their 2016 Premature Battery Depletion Advisory.
Contact us on pursuing a claim for any injury or loss occasioned by the defibrillator defect. We can assist you and your family to obtain recovery for your losses.