| Z-0016-2011 |
Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798
CONTAK RENEWAL 4/4RF Models H190*, H195*, H197*, H199*, M170*, M175*, M177*, M179*, H230*, H235*, H239*
*Not available in the US
Reason: Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs (CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE implantable defibrillators). This prevents delivery of programmed tachy therapy, and use of the Patient Triggered Monitor feature. This issue may require
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2010-07-22 |
Terminated
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| Z-0017-2011 |
Guidant, Vitality HE ICD, Model: T180DDR, Sterile Lot, Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798.
Reason: Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs (CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE implantable defibrillators). This prevents delivery of programmed tachy therapy, and use of the Patient Triggered Monitor feature. This issue may require
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2010-07-22 |
Terminated
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| Z-0025-2014 |
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Reason: The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
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2013-08-29 |
Terminated
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| Z-0026-2014 |
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
Reason: The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
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2013-08-29 |
Terminated
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| Z-0037-2012 |
LATITUDE Paceart Integration Software, version 1.00 Model 6472.
LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distributed on USB pen drives. These pen drives are lot number controlled and denoted as Model 6493.
When used in conjunction with the LATITUDE EMR Integration software transfers data files from the Boston Scientific LATITUDE Patient Management system to a clinic's Paceart system.
Reason: Boston Scientific has determined that under certain conditions, LATITUDE Paceart Integration (LPI) software
may not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.
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2011-08-12 |
Terminated
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