October 11 2016 – The devices addressed in this communication are the following St. Jude Medical ICD and CRT-D models manufactured before May 2015.
Impacted Models
Fortify VR
Fortify ST VR
Fortify Assura VR
Fortify Assura ST VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Fortify Assura ST DR
Unify
Unify Quadra
Unify Assura
Quadra Assura
Quadra Assura MP
Background of Recall
FDA is providing information and recommendations regarding St. Jude Medical’s advisory on ICD and CRT-D batteries that may fail earlier than expected. FDA and St. Jude Medical are alerting patients, patient-caregivers, and physicians to respond immediately to Elective Replacement Indicator (ERI) alerts. Due to problems with these batteries, patients do not 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. St. Jude Medical has initiated a recall and correction of the affected devices.
HRS Recommendations
HRS recommends that physicians contact all of their affected patients to reinforce the FDA’s recommendations and schedule office visits to discuss the details of the safety communication. Physicians, patients and their care-givers should determine the best course of action based on individuals’ medical history, comorbidities, and clinical conditions.
HRS strongly supports the FDA’s recommendation to employ remote monitoring to assist in the early detection of premature battery depletion. This is consistent with the recent HRS Expert Consensus Statement on Remote Interrogation and Monitoring for Cardiovascular Electronic Implantable Devices, which includes a Class I recommendation (level of evidence A) for monitoring all patients.
Topic
- Regulatory
- U.S. Food and Drug Administration (FDA)
Resource Type
- Safety Alerts
Manufacturer
- Other
Device Type
- ICDs & CRT-Ds
Related Resources

Safety Alerts
Biosense Webster Advisory: Update to the Instructions for Use for VARIPULSE
March 26, 2025

Safety Alerts
Abbott Advisory: Manufacturing Defect Associated with Loss of Pacing for a Limited Subset of Assurity™ and Endurity™ Pacemakers
February 18, 2025

Safety Alerts
Philips Urgent Medical Device Correction: Mobile Cardiac Telemetry (MCT) or Event Diagnostic Service Processing
February 5, 2025