The Recall Desk

FDA (Devices) recall action 75393

St Jude Medical Inc. recalled 3 products on 2016-11-02

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2016-11-02
Critical
1
Units
603,524

Why these products were recalled

St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.

St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.

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.

1–3 of 3

  • SevereFDA (Devices)··2016-11-02

    St Jude Medical Recalls ICD and CRT-D Devices for Battery Short Circuit

    St Jude Medical is recalling implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators due to a battery defect that can cause premature depletion.

    Product
    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-11-02

    St Jude Medical Recalls Implantable Cardiac Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because a lithium cluster in the battery can cause a short circuit and premature battery depletion.

    Product
    Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40…
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2016-11-02

    St Jude Medical Recalls Implantable Defibrillators Due to Battery Defect

    St Jude Medical is recalling specific implantable defibrillators because a lithium cluster in the battery can cause a short circuit and premature depletion.

    Product
    Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia…
    Category
    Distribution
    0 states