Announcement: St. Jude Medical Defibrillator Recall
St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion
Recalled Product(s):
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
Device Use
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
Reason for Recall
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.
Who May be Affected
- Patients with a St. Jude Medical ICD or CRT-D device
- Caregivers of patients with a St. Jude Medical ICD or CRT-D device
- Health care providers treating patients with heart failure or heart rhythm problems using St. Jude Medical ICD or CRT-D devices
What to Do
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.
Full List of Affected Devices
- Fortify VR: Model No(s). CD1231-40, CD1231-40Q
- Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
- Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C
- Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
- Fortify DR: Model No(s). CD2231-40, CD2231-40Q
- Fortify ST DR: Model No(s). CD2241-40, CD2241-40Q
- Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
- Fortify Assura ST DR: Model No(s). CD2263-40, CD2363-40C, CD2363-40Q
- Unify: Model No(s). CD3231-40, CD3231-40Q
- Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
- Unify Assura: Model No(s). CD3257-40, CD3357-40C, CD3357-40Q
- Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
- Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C
Contact Foley & Small
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.