Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricula

Is my product affected?

Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

• UPC 00613994425010

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling 1,867 units of the EnTrust Escudo D144DRG implantable cardioverter defibrillator (ICD) distributed worldwide and in the US. The devices may lose high voltage and anti-tachycardia pacing therapy as the battery approaches end-of-life. In certain circumstances, the device may immediately display an End of Life Observation without first showing an Elective Replacement Indicator alert, and the remaining battery capacity may be insufficient to charge the high voltage circuits, resulting in excessive charge time and loss of therapy.

The affected devices are identified by specific serial numbers beginning with "PNR611" followed by additional digits and the letter "S." The record does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide Distribution - US Nationwide Quantity: 1867 units Lot/code info: Product UPN/GTIN: 00613994425010 Serial Numbers: PNR611652S PNR611653S PNR611654S PNR611655S PNR611656S PNR611657S PNR611658S PNR611659S PNR611661S PNR611662S PNR611663S PNR611664S PNR611665S PNR611666S PNR611667S PNR611669S PNR611670S PNR611671S PNR611672S PNR611673S PNR611674S PNR611675S PNR611724S PNR611726S PNR611728S PNR611730S PNR611734S PNR611735S PNR611738S PNR611743S PNR611746S PNR611749S PNR611750S PNR611751S PNR611752S PNR611753S PNR611754S PNR611755S PNR611756S PNR611757S PNR611758S PNR611759S PNR611761S PNR611762S PNR611763S PNR611764S PNR611765S PNR611767S PNR611768S PNR611861S PNR611862S PNR611863S PNR611864S PNR611865S PNR611866S PNR611867S PNR611868S PNR611869S PNR611870S PNR611871S PNR611872S PNR611873S PNR611875S PNR611876S PNR611877S PNR611878S PNR611879S PNR611880S PNR611881S PNR611883S PNR611884S PNR611885S PNR611886S PNR611888S PNR611889S PNR611891S PNR611892S PNR611893S PNR611894S PNR611895S PNR611896S PNR611897S PNR611898S PNR611899S PNR611900S PNR611901S PNR611902S PNR611903S PNR611904S PNR611905S PNR611909S PNR611916S PNR611917S PNR611929S PNR611930S PNR611931S PNR611933S PNR611934S PNR611936S PNR611937S PNR611938S PNR611939S PNR611940S PNR611941S PNR611943S PNR611944S PNR611945S PNR611947S PNR611948S PNR611955S PNR611956S PNR611957S PNR611958S PNR611959S PNR611961S PNR611962S PNR611964S PNR611978S PNR611979S PNR611980S PNR611981S PNR611982S PNR611983S PNR611984S PNR611985S PNR611986S PNR611987S PNR611988S PNR611989S PNR611990S PNR611991S PNR611992S

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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