St. Jude ICD Recall Is Deemed a Class I by Federal Regulators

St. Jude recently reported two patient deaths tied to early depletion of lithium batteries in St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D).

The U.S. Food and Drug Administration (FDA) and St. Jude issued an alert to patients, caregivers, and physicians, asking that they immediately respond to elective replacement indicator alerts from the devices. This week, the FDA announced that a Class 1 recall designation had been made for the St. Jude Medical recall over hundreds of thousands of ICDs that are reported to suffer premature battery depletion problems, according to QMed.

The Class 1 designation is the agency’s most serious and involves “a situation in which there is a reasonable probability that the use of or exposure to a violative product”—in this case, the St. Jude’s ICD and CRT-D—“will cause serious adverse health consequences or death,” according to the agency.

St. Jude Medical ICDs and CRT-Ds provide heart rhythm pacing for bradycardia (slow heart rhythms), electrical shock or pacing to stop tachycardia (dangerously fast heart rhythms), or to coordinate heart rhythm to treat heart failure. The devices are implanted under the skin in the upper chest with connecting insulated wires—leads—that enter the heart.

A total of 349,852 affected devices remain actively implanted worldwide. Of these, 251,346 are implanted in patients in the United States, QMed noted. Rapid battery failure appears to be the result of lithium deposits, known as lithium clusters, forming within the battery, which may lead to a short circuit.

This recall involves the following:

  • Fortify, Unify, and Assura ICDs and CRT-Ds
  • Manufacturing Dates: January 2010 to May 2015
  • Distribution Dates: February 2010 to October 2016
  • Devices Recalled in the U.S.: 251,346 Nationwide

If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and receive a replacement, the ICD or CRT-D will not be able to deliver life-saving pacing or shocks. This defect could lead to patient death.

On October 10, 2016, St. Jude Medical issued notification letters to customers and health care providers of the possibility of premature battery depletion in affected ICD and CRT-D devices. On October 11, 2016, the FDA issued a safety notification concerning the recall, providing recommendations for health care providers, patients, and caregivers.

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, 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
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