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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is inte
Recalled July 18, 2018 · FDA recall Z-2421-2018 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →