Category Archives: Medical Recalls

Defective St. Jude ICD / CRT-D Devices

Defective St. Jude ICD / CRT-D Devices

assura-ellipseSt. Jude Medical Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices – Early Battery Depletion

If you are a New York user of a St. Jude Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D), you need to be aware of a major defect in the device’s battery that can lead to injury or death at worst, and necessitate immediate replacement of the device at best.

Due to conductive lithium deposits in the battery, it can possibly deplete rapidly enough to lose all power within a 24-hour window. This renders the device completely inoperable. Under normal circumstances, a user of one of these devices would have a significant warning as to a nearly depleted battery, and would be able to plan a replacement far in advance. The potential of a catastrophic and sudden device failure presents a situation where the typical “Elective Replacement Indicator” (ERI) signal may only come 24 hours before the device ceases to function, and many are forced to have their devices replaced immediately.

This defect is not acceptable for such a medical device, as it puts patients’ health at grave risk. Failure of the device to operate can and has led to serious injuries to users of the devices, as well as forcing premature procedures to replace the devices. If you, a family member, or someone you know has been put in this situation, or currently has one of these devices, we implore you to call us. We can help recover money for injuries or other complications stemming from these defective medical devices. We can be reached at 800-734-9445, or via email at Info@RGLZlaw.com.

Relevant FDA Notices

FDA Safety Communications
FDA MedWatch Safety Alert