Update of Class I Recall of St. Jude Medical's Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators

PUBLISHED: Oct 20, 2017
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Medical Office/Clinic

This recall notice updates the Food and Drug Administration (FDA)’s October 2016 recall notice about St. Jude Medical’s Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators 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.

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.

Persons who may be affected by this recall include:

  • 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

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.

Please follow the link below for additional information including a full listing of recalled product.

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