Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; 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: 12 units Lot/code info: GTIN 00643169720763, Lot Serial Numbers: BWT600023S, BWT600013S, BWT600014S, BWT600025S, BWT600029S, BWT600030S, BWT600032S, BWT600033S, BWT600034S, BWT600024S,; GTIN 00763000052706, Lot Serial Numbers: BWT600040S, BWT600038S

UPC codes

00643169720763, 00763000052706

Source

Official record: FDA (Device enforcement) ↗

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