Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide - Worldwide Distribution Quantity: 20 units Lot/code info: GTIN 00643169720558, Lot Serial Numbers: PKZ212063H, PKZ212047H, PKZ212048H, PKZ212049H, PKZ212050H, PKZ212055H, PKZ212061H, PKZ212062H, PKZ212042H, PKZ212039H, PKZ212041H, PKZ212027H, PKZ212032H, PKZ212033H, PKZ212035H, PKZ212044H, PKZ212053H, PKZ212054H, PKZ212056H, PKZ212057H

UPC codes

00643169720558

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.