St. Jude recalled Fortify, Unify, and Assura defibrillators because the battery can deplete prematurely. Patients may need emergency surgery to replace the defibrillator or suffer death.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting St. Jude defibrillator induced injury cases in all 50 states. If you or somebody you know suffered death or needed emergency replacement surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the problem?
In August 2017, St. Jude Medical initiated a Class I recall for about 175,625 defibrillators because the battery can run out too soon. Unless the patient undergoes an emergency replacement surgery, they can suffer death.
St. Jude Defibrillator Recall
St. Jude has recalled the Fortify, Unify, and Assura (including Quadra) Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) that were distributed to doctors between February 2010 and October 2016.
The recalled ICDs and CRT-Ds provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. They are used to treat patients with heart failure or heart rhythm disorders. The defibrillators are implanted under the patient’s skin in the upper chest area with wires called “leads” that go into the heart.
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
Battery Performance Alert
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 (ICDs).
What Should I Do?
If a BPA is triggered, the doctor will be notified. St. Jude Medical recommends emergency surgery to remove and replace the device.
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.
Do I have a St. Jude Defibrillator Lawsuit?
The Schmidt Firm, PLLC is currently accepting St. Jude Defibrillator induced injury cases in all 50 states. If you or somebody you know suffered death or needed emergency replacement surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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