Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; 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: 3005 units Lot/code info: GTIN 00643169837690, Lot Serial Numbers: RPV203851H, RPV203879H, RPV204192H, RPV204308H, RPV205279H, RPV205423H, RPV205665H, RPV205443H, RPV205510H, RPV204476H, RPV205107H, RPV204152H, RPV204326H, RPV204327H, RPV204329H, RPV203937H, RPV204831H, RPV204911H, RPV205343H, RPV205351H, RPV205497H, RPV205762H, RPV205763H, RPV205785H, RPV203840H, RPV204908H, RPV205661H, RPV203773H, RPV203795H, RPV203808H, RPV204568H, RPV205383H, RPV205713H, RPV205312H, RPV205849H, RPV204239H, RPV205251H, RPV203909H, RPV204821H, RPV205370H, RPV205812H, RPV205832H, RPV205093H, RPV204730H, RPV204741H, RPV204553H, RPV203983H, RPV205414H, RPV205597H, RPV205682H, RPV205541H, RPV204597H, RPV204711H, RPV205219H, RPV205645H, RPV205215H, RPV205056H, RPV203988H, RPV204130H, RPV204198H, RPV204610H, RPV205672H, RPV205843H, RPV205358H, RPV205484H, RPV205614H, RPV204042H, RPV204393H, RPV204418H, RPV204768H, RPV205338H, RPV205636H, RPV204270H, RPV205806H, RPV204735H, RPV204785H, RPV204806H, RPV205115H, RPV205117H, RPV205118H, RPV205120H, RPV205257H, RPV205259H, RPV205320H, RPV205337H, RPV205356H, RPV205384H, RPV205436H, RPV205442H, RPV205593H, RPV205756H, RPV205775H, RPV205811H, RPV203905H, RPV204228H, RPV204229H, RPV204681H, RPV204682H, RPV204959H, RPV205211H, RPV205288H, RPV205299H, RPV204872H, RPV203738H, RPV203780H, RPV203783H, RPV203787H, RPV203861H, RPV204026H, RPV204037H, RPV204128H, RPV204527H, RPV204535H, RPV204929H, RPV204930H, RPV204938H, RPV204941H, RPV204942H, RPV204950H, RPV204952H, RPV205372H, RPV2054

UPC codes

00643169837690, 00763000059606

Source

Official record: FDA (Device enforcement) ↗

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