Recall Z-2416-2018— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2018-06-21, terminated 2021-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153ATG Product Usage: The device indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.. Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they near elective replacement indicator (ERI) voltage. Under certain circumstances, the device may display an immediate End of Life (EOL) Observation with no prior ERI alert. Though no ERI alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time EOL Observation, leading to a loss of high voltage and anti-tachycardia pacing therapy..

Recalling firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Classification

Class II

Status

Terminated

Initiated

2018-06-21

Terminated

2021-06-16

Firm location

Mounds View, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.