We urge our membership to please be aware of two recent medical device recalls. The FDA has identified both of these as Class I recalls. Use of these devices may cause serious injuries or death.

St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion

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.

Please visit here for a full list of affected devices, as well as resources and contact information related to the St. Jude Medical recall.

HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues

Additionally, HeartWare Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.

Please visit here for a full list of affected devices, as well as resources and contact information related to the HeartWare recall.