Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; 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: 11794 units Lot/code info: GTIN 00643169837676, Lot Serial Numbers: RPT208454H, RPT211000H, RPT208258H, RPT211071H, RPT211077H, RPT210886H, RPT209224H, RPT211338H, RPT211343H, RPT211344H, RPT211347H, RPT208864H, RPT210392H, RPT204063H, RPT207540H, RPT210779H, RPT211477H, RPT210662H, RPT203810H, RPT204233H, RPT210695H, RPT204352H, RPT204713H, RPT205727H, RPT208222H, RPT208507H, RPT210829H, RPT211217H, RPT206139H, RPT207062H, RPT210688H, RPT210917H, RPT203993H, RPT205235H, RPT205768H, RPT206518H, RPT206833H, RPT209343H, RPT209843H, RPT205560H, RPT206519H, RPT210915H, RPT210978H, RPT207320H, RPT204196H, RPT205788H, RPT207588H, RPT209206H, RPT209796H, RPT210253H, RPT210444H, RPT210700H, RPT211542H, RPT211685H, RPT205575H, RPT205841H, RPT207926H, RPT204420H, RPT205180H, RPT204120H, RPT204133H, RPT209974H, RPT205340H, RPT209909H, RPT210452H, RPT211124H, RPT203859H, RPT205468H, RPT208257H, RPT208621H, RPT209674H, RPT211043H, RPT210842H, RPT211476H, RPT207094H, RPT208370H, RPT206004H, RPT206049H, RPT210092H, RPT210217H, RPT211406H, RPT204980H, RPT205294H, RPT208424H, RPT208705H, RPT209144H, RPT209238H, RPT209858H, RPT210083H, RPT210593H, RPT210747H, RPT210979H, RPT211230H, RPT211701H, RPT209577H, RPT209848H, RPT211158H, RPT205289H, RPT206148H, RPT209521H, RPT204605H, RPT206936H, RPT207571H, RPT209334H, RPT209373H, RPT204461H, RPT207429H, RPT209096H, RPT210964H, RPT211140H, RPT205903H, RPT208605H, RPT211566H, RPT206634H, RPT203640H, RPT203792H, RPT203793H, RPT203795H, RPT204568H, RPT204574H, RPT204577H, RPT2045

UPC codes

00643169837676

Source

Official record: FDA (Device enforcement) ↗

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