Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; 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: 7 units Lot/code info: GTIN 00643169980181, Lot Serial Numbers: BLQ600039S, BLQ600033S, BLQ600034S, BLQ600035S, BLQ600036S, BLQ600037S, BLQ600038S

UPC codes

00643169980181

Source

Official record: FDA (Device enforcement) ↗

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