The Recall Desk

FDA (Devices) recall action 77983

Sorin Group Italia SRL - CRF recalled 6 products on 2017-10-04

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
2017-10-04
Critical
0
Units
711

Why these products were recalled

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

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)··2017-10-04

    Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group Italia SRL is recalling Platinium DR 1510 ICDs due to a possibility of overconsumption following ElectroStatic Discharge (ESD) during implant surgery or MRI scans.

    Product
    Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-10-04

    Sorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI

    Sorin Group is recalling 68 Platinium CRT-D devices due to a possibility of overconsumption of the device following electrostatic discharge or an MRI scan.

    Product
    Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients wh
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-10-04

    Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling 72 Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
    Category
    Distribution
    0 states