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 St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Click here for more FDA information.

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.
 

Fortify Assura VR ICD, and a Quadra Assura CRT-D
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

 
Contact your doctor as soon as possible regarding the situation.
 

On August 28, 2017, St. Jude Medical notified physiciansdisclaimer icon 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 Advisorydisclaimer icon.

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.

Tell us about your loss.

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