St. Jude Medical Defibrillators Recall

Why is there a recall?

St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)  provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.  They are implanted in the upper chest are with connecting wires called leads that go into the heart.

Some devices manufactured prior to May 23, 2015 contain batteries which could run out of energy earlier than expected i.e. premature battery depletion.

FDA and St. Jude Medical are alerting patients, patient-caregivers and physicians to respond immediately to ERI alerts.  Due to problems with these batteries, patients don’t have the normal 3-month lead time for device replacement.  Some batteries have run out within 24 hours of the patient receiving an ERI alert (an alert warning that the battery will need to be replaced soon).  If the battery runs out the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.

As of March 2017, the worldwide experience for the affected devices that were returned for product analysis due to premature battery depletion are: 40 people reported dizziness, 11 people fainted, 1 person had an emergency loss of defibrillation, and 2 people died.

What devices does the recall affect?

The recall affects the Fortify, Unify and Assura ICD CRT-D devices manufactured between January 2010 and May 2015.  The devices were distributed between February 2010 and October 2016.

On the St. Jude Medical website one can put in their device’s model # and serial # to see if they are subject to the advisory.

The following devices have been affected:

  • 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

If you or a loved one has been the victim of an injury from using a product or have been misled or deceived about a product or service, contact the law firm of Henrichsen Siegel, P.L.L.C. right away to find out your legal rights as a consumer.



Leave a Comment