Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; 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: 14 units Lot/code info: GTIN 00643169968585, Lot Serial Numbers: BLC229283H, BLC229226H, BLC229270H, BLC229280H, BLC229229H, BLC228997H, BLC229238H, BLC229043H, BLC229231H, BLC229046H, BLC229045H, BLC229230H, BLC228995H, BLC229010H

UPC codes

00643169968585

Source

Official record: FDA (Device enforcement) ↗

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