Class 1 Recall: 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.
 
Recalled Product(s):
 
  • Fortify, Unify, and Assura 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.: 251,346 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.
 
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.
 
Reason for Recall
 
St. Jude Medical is recalling certain models of the Fortify, Unify, and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium (known as “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.
 
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 October 10, 2016, St. Jude Medical sent notification letters to customers and health care providers informing them of the possibility of premature battery depletion in affected ICD and CRT-D devices.
 
Additionally, on October 11, 2016, the FDA issued a safety communication regarding this recall, and provided recommendations for health care providers, patients, and caregivers.
 
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, CD1357-40Q
  • 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, CD-2241-40Q, CD2263-40, CD2263-40Q
  • Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
  • Fortify Assura ST DR: Model No(s). 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, CD3257-40Q, 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 Information
 
Customers with questions may contact St. Jude Medical Customer Service at: 1-866-915-5065.
 
 
Date Recall Initiated
 
October 10, 2016
 
 
 

The FDA alerts provided by MedWrench are intended to be helpful reminders, but are not to displace the timely alerts provided by the manufacturers of the products or the FDA directly. You should always consult those services prior to making any final decisions as to the timeliness and accuracy of the FDA alerts we distribute. For more visit www.fda.gov.