FDA Designates St. Jude ICD & CRT-D Battery Recall Class I

Published on October 25, 2016 by Sandy Liebhard

U.S. health regulators have designated St. Jude Medical’s recent ICD and CRT-D battery recall Class I, the most serious classification possible. The U.S. Food & Drug Administration (FDA) only declares Class I recalls when the use of a device may cause serious injuries or death.

St. Jude Medical initially announced the recall on October 10th, following reports of premature battery depletion affecting some of the company’s implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). These devices provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. According to the FDA’s October 24th notice, ICDs and CRT-Ds affected by the St. Jude recall include:

• 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

All of the affected devices were manufactured from January 2010 to May 2015, and distributed from February 2010 to October 2016. In a Safety Communication issued on October 11^th, the FDA noted that 398,740 recalled ICDs and CRT-Ds had been sold worldwide. The U.S. recall includes 251,346 implants.

FDA Recommendations

If a battery fails prematurely, an ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. So far, two deaths (1 in the U.S.) have been linked to this problem. Ten additional patients, (9 in the U.S), reported fainting from devices that could not provide needed pacing therapy due to premature battery depletion. Another 37 (30 in the U.S.) have reported dizziness. Of the implants sold worldwide, 841 have been returned to St. Jude for analysis due to premature battery depletion.

The FDA’s October 11^th Communications included recommendations to mitigate the risks associated with premature battery depletion. Among other things, the agency advised that affected patients register for St. Jude Medical’s Merlin@home remote transmitter system in order to monitor their devices for premature battery failure. However, this could prove problematic, as it was recently alleged that certain St. Jude cardiac devices, including the Merlin@home system, are vulnerable to hacking. In fact, the FDA is actively investigating those allegations.

The FDA has also cautioned that its recommended mitigations may not be sufficient or appropriate for some patients implanted with the recalled ICDs and CRT-Ds. “Health care providers should consider whether elective device replacement is warranted for their pacemaker dependent patients,” the FDA said.