St. Jude Defibrillator and Therapy Device Recall

Individuals who have had a St. Jude Defibrillator implanted to provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms may have received one of 175,624 devices nationwide in the United States that has been recalled due to premature battery depletion.

The batteries that are allegedly defective and that led to St. Jude’s ICDs being recalled are not the original batteries designed for these devices. Instead, the allegedly defective batteries were designed and used in St. Jude devices after the devices and original power sources were approved by the FDA. St. Jude announced the new batteries as an improvement over the original power source, designed to last longer than the original. By 2014, however, it was clear that St. Jude knew these newer, “improved” batteries had problems.

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.

ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

Full List of Affected Devices

Model/Item Numbers: See “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

 

Recalled Product(s): Fortify, Unify, and Assura (including Quadra) Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)

Manufacturing Dates: January 2010 to May 2015

Distribution Dates: February 2010 to October 2016

Devices Recalled in the U.S.: 175,624 Nationwide

Side Effects And Symptoms Of A Defective St. Jude Defibrillator

"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."

Individuals who have had a St. Jude defibrillator implanted and who experience any of the following symptoms should proceed to the nearest emergency room and/or obtain immediate medical treatment. Those affected may be eligible for compensation:

  • Chest pain
  • Lightheadedness
  • Dizziness
  • Loss of consciousness
  • Shortness of breath

St. Jude Defibrillator 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

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