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.
- 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.
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.
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
Customers with questions regarding patient management, including observed changes in battery longevity, should contact your local Sales Representative or Abbot Technical Services at 1-(800)-722-3774, which is available 24 hours a day, 7 days a week.
Date Recall Initiated
August 28, 2017
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.