Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781045
TELEFLEX
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040
TELEFLEX
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781065
TELEFLEX
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Limacorporate S.p.A
Class I - Dangerous
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Class I - Dangerous
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Class I - Dangerous
TC-I tip clip sensor may produce readings outside the accuracy specification.
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class I - Dangerous
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.