Medtronic Issues Class I Recall For Select CRT-Ds, ICDs Due to Critical Manufacturing Error

Medtronic recently issued a Class I recall for certain Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) due to a manufacturing defect that may prevent life-saving electrical shock delivery. The defect causes an out of specification gas mixture within the device which may result in a failure to provide pacing for patient heart rhythms. This malfunction can lead to serious injury or death. A total of 48 units have been recalled nationwide. Affected devices were manufactured between July 13, 2013, and Aug. 8, 2017, and include product codes NIK and LWS. Read a complete list of affected serial numbers here. Health care professionals and consumers should report adverse reactions or quality problems related to these devices through the U.S. Food and Drug Administration Safety Information and Adverse Event Reporting Program.

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

Keywords: ACC Advocacy, Cardiac Resynchronization Therapy, United States Food and Drug Administration, Electric Countershock, Defibrillators, Implantable, Death

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