Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; 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: 373 units Lot/code info: GTIN 00643169720190, Lot Serial Numbers: BLD212440H, BLD212962H, BLD212366H, BLD212449H, BLD212473H, BLD212554H, BLD212653H, BLD212675H, BLD212791H, BLD212822H, BLD212902H, BLD212926H, BLD213003H, BLD213009H, BLD212351H, BLD212699H, BLD212811H, BLD212406H, BLD212432H, BLD212306H, BLD212443H, BLD212455H, BLD212472H, BLD212600H, BLD212644H, BLD212839H, BLD212920H, BLD212943H, BLD212349H, BLD212311H, BLD212708H, BLD212781H, BLD212834H, BLD212521H, BLD212566H, BLD212628H, BLD212648H, BLD212782H, BLD212883H, BLD213061H, BLD212483H, BLD212487H, BLD213006H, BLD212452H, BLD212752H, BLD213012H, BLD212357H, BLD212333H, BLD212570H, BLD212638H, BLD212709H, BLD212830H, BLD212915H, BLD212953H, BLD212984H, BLD212996H, BLD213030H, BLD213041H, BLD212586H, BLD212459H, BLD212721H, BLD212843H, BLD213039H, BLD212917H, BLD212427H, BLD211868H, BLD212522H, BLD212412H, BLD212413H, BLD212415H, BLD212416H, BLD212418H, BLD212767H, BLD212842H, BLD212878H, BLD212879H, BLD212898H, BLD212909H, BLD213072H, BLD212376H, BLD212702H, BLD212556H, BLD211866H, BLD212723H, BLD211867H, BLD212688H, BLD212565H, BLD212615H, BLD212627H, BLD212732H, BLD212785H, BLD212912H, BLD212919H, BLD212951H, BLD212993H, BLD213011H, BLD213015H, BLD213032H, BLD213042H, BLD213052H, BLD213053H, BLD212774H, BLD212783H, BLD213035H, BLD213049H, BLD212835H, BLD212538H, BLD212411H, BLD212809H, BLD212925H, BLD213060H, BLD212358H, BLD212762H, BLD212813H, BLD212578H, BLD212625H, BLD212626H, BLD212552H, BLD212729H, BLD212368H, BLD212423H, BLD2124

UPC codes

00643169720190

Source

Official record: FDA (Device enforcement) ↗

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