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Medical Devices

Medical Devices Recalls

Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.

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Showing 5141–5160 of 8393 recalls

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Primo MRI ICD (Medtronic) – Therapy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICD-VR Evera MRI XT (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Evera MRI ICD (Medtronic) – Therapy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CRTD Compia MRI (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICD Crome VR MRI (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Cobalt XT DR MRI ICD (Medtronic) – Therapy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICD-VR Evera S (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CRTD Compia MRI Quad (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Visia AF MRI ICD (Medtronic) – Therapy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Evera MRI ICD (Medtronic) – Therapy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Viva XT CRT-D (Medtronic) – Therapy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

PushTracker E3 (Permobil) – CPU Processing Risk (2023)

When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail unexpectedly. If this happens, the motor on the power assist device continues to run and the user may not be able to stop the device using tap gestures.

FDAMay 10, 2023Nationwide• Permobil

Visia MRI ICD (Medtronic) – Therapy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICD-DR Evera S (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICD-VR Evera S (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICD-DR Evera MRI XT (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

ICD-VR Visia MRI (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CRTD Compia MRI Quad (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CRTD Cobalt XT HF MRI (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

CRTD Amplia MRI Quad (Medtronic) – Energy Output Risk (2023)

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.

FDAMay 10, 2023Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

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