Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; 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: 6 units Lot/code info: GTIN 00763000615628, Lot Serial Numbers: RSM616778S, RSM610606S, RSM611337S, RSM610608S, RSM611339S; GTIN 00763000645502, Lot Serial Numbers: RSM616777S

UPC codes

00763000615628, 00763000645502

Source

Official record: FDA (Device enforcement) ↗

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