Class I Recall of St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
St. Jude Medical is recalling certain models of the Fortify, Unify, and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit. If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
The FDA issued a safety communication regarding this recall, and provided recommendations for health care providers, patients, and caregivers on October 11, 2016. See the StayAlert Notice from October 11, 2106 for additional information.
- Fortify, Unify, and Assura Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). See recall notice for full list of affected devices.
- Manufacturing Dates: January 2010 to May 2015
- Distribution Dates: February 2010 to October 2016
- Devices Recalled in the U.S.: 251,346 Nationwide
On October 10, 2016, St. Jude Medical sent notification letters to customers and health care providers informing them of the possibility of premature battery depletion in affected ICD and CRT-D devices.
St. Jude Medical ICDs and CRT-Ds are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D for bradycardia, tachycardia, or if the patient needs coordination to treat heart failure.
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