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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1485-2022

Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4

Publicado el 17 de agosto de 2022 · Inicio del retiro: 22 de junio de 2022

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Distribuidor
Worldwide Distribution
Lote
a. Model Numbers: DVPA2D1: GTIN 00763000178451, Serial Numbers: RSC600237S, RSC600256S, RSC600277S, RSC600327S, RSC600419S, RSC601038S, RSC601061S, RSC601065S, RSC601084S, RSC601126S, RSC601134S, RSC601138S, RSC601158S, RSC601159S, RSC601175S, RSC601193S, RSC601209S, RSC601210S, RSC601213S, RSC601214S, RSC601217S, RSC601226S, RSC601242S, RSC601244S, RSC601249S, RSC601313S, RSC601314S, RSC601315S, RSC601317S, RSC601323S, RSC601330S, RSC601332S, RSC601337S, RSC601341S, RSC601342S, RSC601346S, RSC601349S, RSC601354S, RSC601358S, RSC601370S, RSC601372S, RSC601377S, RSC601379S, RSC601397S, RSC601402S, RSC601411S, RSC601420S, RSC601422S, RSC601438S, RSC601441S, RSC601446S, RSC601453S, RSC601467S, RSC601473S, RSC601476S, RSC601486S, RSC601493S, RSC601494S, RSC601500S, RSC601506S, RSC601510S, RSC601511S, RSC601516S, RSC601520S, RSC601525S, RSC601526S, RSC601532S, RSC601539S, RSC601542S, RSC601581S, RSC601622S, RSC601627S, RSC601628S, RSC601631S, RSC601635S, RSC601636S, RSC601644S, RSC601650S, RSC601651S, RSC601659S, RSC601674S, RSC601676S, RSC601678S, RSC601680S, RSC601681S, RSC601683S, RSC601690S, RSC601693S, RSC601694S, RSC601696S, RSC601697S, RSC601698S, RSC601699S, RSC601702S, RSC601704S, RSC601705S, RSC601707S, RSC601708S, RSC601712S, RSC601714S, RSC601721S, RSC601722S, RSC601726S, RSC601733S, RSC601756S; GTIN 00763000178475, Serial Numbers: RSC600021S, RSC600025S, RSC600029S, RSC600031S, RSC600037S, RSC600053S, RSC600056S, RSC600059S, RSC600062S, RSC600063S, RSC600077S, RSC600223S, RSC600227S, RSC600309S, RSC600315S, RSC600403S, RSC600405S, RSC600410S, RSC600459S, RSC600460S, RSC600463S, RSC600469S, RSC600479S, RSC600509S, RSC600518S, RSC600523S, RSC600524S, RSC600525S, RSC600526S, RSC600529S, RSC600538S, RSC600540S, RSC600542S, RSC600543S, RSC600554S, RSC600555S, RSC600560S, RSC600562S, RSC600564S, RSC600569S, RSC600571S, RSC600572S, RSC600573S, RSC600575S, RSC600577S, RSC600578S, RSC600581S, RSC600586S, RSC600588S, RSC600598S, RSC600599S, RSC600606S, RSC600610S, RSC600613S, RSC600616S, RSC600618S, RSC600619S, RSC600620S, RSC600621S, RSC600670S, RSC600671S, RSC600675S, RSC600676S, RSC600677S, RSC600683S, RSC600685S, RSC600688S, RSC600689S, RSC600691S, RSC600692S, RSC600694S, RSC600695S, RSC600697S, RSC600698S, RSC600699S, RSC600701S, RSC600704S, RSC600707S, RSC600709S, RSC600710S, RSC600711S, RSC600713S, RSC600714S, RSC600717S, RSC600718S, RSC600721S, RSC600722S, RSC600725S, RSC600726S, RSC600729S, RSC600730S, RSC600732S, RSC600733S, RSC600734S, RSC600735S, RSC600737S, RSC600739S, RSC600740S, RSC600741S, RSC600742S, RSC600745S, RSC600746S, RSC600747S, RSC600748S, RSC600749S, RSC600750S, RSC600751S, RSC600753S, RSC600754S, RSC600756S, RSC600759S, RSC600760S, RSC600761S, RSC600763S, RSC600764S, RSC600767S, RSC600768S, RSC600769S, RSC600771S, RSC600772S, RSC600773S, RSC600775S, RSC600776S, RSC600778S, RSC600779S, RSC600780S, RSC600781S, RSC600782S, RSC600783S, RSC600785S, RSC600786S, RSC600787S, RSC600788S, RSC600789S, RSC600790S, RSC600792S, RSC600793S, RSC600794S, RSC600795S, RSC600796S, RSC600797S, RSC600798S, RSC600799S, RSC600800S, RSC600804S, RSC600806S, RSC600807S, RSC600808S, RSC600809S, RSC600810S, RSC600811S, RSC600812S, RSC600814S, RSC600816S, RSC600817S, RSC600823S, RSC600825S, RSC600826S, RSC600827S, RSC600830S, RSC600831S, RSC600832S, RSC600835S, RSC600837S, RSC600840S, RSC600841S, RSC600842S, RSC600843S, RSC600844S, RSC600846S, RSC600851S, RSC600852S, RSC600857S, RSC600858S, RSC600863S, RSC600864S, RSC600865S, RSC600869S, RSC600870S, RSC600874S, RSC600876S, RSC600880S, RSC600881S, RSC600884S, RSC600890S, RSC600891S, RSC600892S, RSC600893S, RSC600894S, RSC600904S, RSC600907S, RSC600908S, RSC600910S, RSC600911S, RSC600913S, RSC600914S, RSC600915S, RSC600916S, RSC600921S, RSC600922S, RSC600926S, RSC600927S, RSC600929S, RSC600930S, RSC600958S, RSC600959S, RSC600960S, RSC600961S, RSC600963S, RSC600964S, RSC600965S, RSC600966S, RSC600967S, RSC600968S, RSC600969S, RSC600986S, RSC600987S, RSC601003S, RSC601005S,
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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