FDA Issues Recall for Defibrillation Electrodes Due to Connection Issues

The U.S. Food and Drug Administration (FDA) issued a Class I recall for Leonhard Lang Multi-function Defibrillation Electrodes DF29N due to a connector compatibility issue with the Welch Allyn automatic external defibrillator (AED) model 10. Used to deliver an electrical shock to individuals experiencing cardiac arrest, the operator may not be able to connect the electrodes to the AED to restore a normal heart rhythm. This delay in providing the necessary electrical therapy may lead to serious injury or death for the patient. There are approximately 8,000 recalled devices in the U.S. distributed between Feb. 14, 2014, and August 3, 2016.

Read the FDA announcement here.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, EP Basic Science, SCD/Ventricular Arrhythmias

Keywords: Defibrillators, Electric Countershock, Heart Arrest, Medical Device Recalls, United States Food and Drug Administration


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