St. Jude recalled the Fortify, Unify, and Assura (including Quadra) ICDs and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) that were distributed between February 2010 and October 2016.
ICDs and CRT-Ds are used to treat patients with heart failure or abnormal heart rhythms. They are implanted under the skin of the chest with a wire “lead” that delivers an electric shock to the heart.
Images of a Fortify Assura VR ICD, and a Quadra Assura CRT-D
The electrical shock is used to restore normal heart rhythm when the defibrillator detects an abnormally slow or dangerously fast heartbeat.
In August 2017, St. Jude announced a new battery performance management tool called the Battery Performance Alert (BPA). It detects abnormal battery performance and notifies physicians.
If the BPA is triggered, the patient will need surgery to replace the defibrillator. If it is not replaced, the patient is at risk of suffering death.
The following is a full list of the recalled defibrillators:
- 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
For more information, or if you notice changes in the battery life of your defibrillator, contact a Sales Representative or Abbot Technical Services at 1-(800)-722-3774 — 24 hours a day, 7 days a week.