Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators
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.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
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.
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