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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRea

Recalled July 18, 2018 · FDA recall Z-2417-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Hazard
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. · FDA Class II
Units
8890 units
Sold at
Worldwide Distribution - US Nationwide

Description

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.

Product
Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154ATG 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.
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRea | RecallWatchUSA