FDA-Device2023-06-28Class I
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
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.
Sold states
US Nationwide - Worldwide Distribution
Affected count
3852 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1816-2023Don't want to check this manually?
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