The Recall Desk

FDA (Devices) recall action 80379

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 6 products on 2018-07-18

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2018-07-18
Critical
0
Units
24,741

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • SevereFDA (Devices)··2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 8,821 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.

    Product
    Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular def
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 3 EnTrust ICDs because they may lose high voltage therapy near battery end-of-life without prior warning.

    Product
    Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular def
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 103 EnTrust Dual Chamber ICDs because they may lose high voltage and anti-tachycardia pacing therapy near end-of-life without prior warning.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-07-18

    Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy

    Medtronic is recalling 1,867 EnTrust Escudo ICDs because they may lose high-voltage therapy without a prior alert.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-07-18

    Medtronic EnTrust ICD Recall for Potential Loss of High Voltage Therapy

    Medtronic is recalling 8,890 EnTrust ICDs due to a potential loss of high voltage therapy near end-of-life. Patients should contact their healthcare provider.

    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
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-07-18

    Medtronic EnTrust Escudo ICD Recall for Potential Loss of Therapy

    Medtronic is recalling EnTrust Escudo ICDs due to a potential loss of high voltage and anti-tachycardia pacing therapy as the battery nears its end of life.

    Product
    Medtronic EnTrust Escudo D144VRC (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.
    Category
    Distribution
    0 states
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 6 products on 2018-07-18 · The Recall Desk