Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; 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 Lot/code info: GTIN 00643169720749, Lot Serial Numbers: RPL202320H, RPL202797H, RPL202825H, RPL203304H, RPL203279H, RPL203319H, RPL203730H, RPL203754H, RPL204075H, RPL202479H, RPL202565H, RPL202842H, RPL203342H, RPL203518H, RPL203521H, RPL203522H, RPL203534H, RPL203543H, RPL203556H, RPL203602H, RPL203718H, RPL203723H, RPL203785H, RPL203210H, RPL202222H, RPL202318H, RPL202555H, RPL202697H, RPL202831H, RPL203172H, RPL202156H, RPL202223H, RPL202514H, RPL203290H, RPL203308H, RPL203446H, RPL202803H, RPL202347H, RPL202465H, RPL202684H, RPL202688H, RPL202707H, RPL202934H, RPL202972H, RPL203031H, RPL203078H, RPL203345H, RPL203399H, RPL203581H, RPL203623H, RPL203688H, RPL202382H, RPL202497H, RPL202590H, RPL203217H, RPL203225H, RPL203363H, RPL203369H, RPL203428H, RPL203479H, RPL203480H, RPL203484H, RPL203487H, RPL203488H, RPL203500H, RPL203513H, RPL203569H, RPL203794H, RPL202376H, RPL202499H, RPL202905H, RPL202940H, RPL203030H, RPL203784H, RPL203795H, RPL203957H, RPL202146H, RPL202538H, RPL202681H, RPL202892H, RPL202973H, RPL203164H, RPL202397H, RPL203253H, RPL203407H, RPL202200H, RPL202294H, RPL202834H, RPL202859H, RPL203075H, RPL203077H, RPL203104H, RPL203388H, RPL203560H, RPL203567H, RPL203574H, RPL203620H, RPL203670H, RPL202172H, RPL202308H, RPL202322H, RPL202336H, RPL202356H, RPL202440H, RPL202470H, RPL202571H, RPL202608H, RPL202765H, RPL202922H, RPL203011H, RPL203067H, RPL203227H, RPL203263H, RPL203265H, RPL203288H, RPL203376H, RPL203631H, RPL203635H, RPL203641H, RPL203642H, RPL203741H, RPL2026

UPC codes

00643169720749, 00763000059996

Source

Official record: FDA (Device enforcement) ↗

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