FDAFDA · Alimentos y medicamentos·N.º oficial Z-1805-2023
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
Publicado el 28 de junio de 2023 · Inicio del retiro: 10 de mayo de 2023
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 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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Distribuidor
- US Nationwide - Worldwide Distribution
- Lote
- GTIN 00643169837805, Lot Serial Numbers: CWH604762S, CWH602704S, CWH604287S, CWH601113S, CWH602355S, CWH601417S, CWH601422S, CWH601423S, CWH603581S, CWH602459S, CWH602700S, CWH601632S, CWH601887S, CWH602686S, CWH602952S, CWH603048S, CWH604506S, CWH604849S, CWH605365S, CWH605366S, CWH605549S, CWH602311S, CWH603176S, CWH603389S, CWH601114S, CWH601326S, CWH601494S, CWH601599S, CWH601907S, CWH601934S, CWH602005S, CWH602031S, CWH602068S, CWH602379S, CWH602640S, CWH602643S, CWH602875S, CWH602966S, CWH603029S, CWH603161S, CWH603186S, CWH604179S, CWH604365S, CWH604848S, CWH605143S, CWH605152S, CWH605229S, CWH605231S, CWH601040S, CWH601241S, CWH602091S, CWH602139S, CWH602556S, CWH602717S, CWH603107S, CWH603227S, CWH603322S, CWH603327S, CWH603472S, CWH603986S, CWH604007S, CWH604304S, CWH604619S, CWH604856S, CWH604885S, CWH604939S, CWH604949S, CWH605132S, CWH605170S, CWH605306S, CWH605355S, CWH605386S, CWH605421S, CWH605553S, CWH601042S, CWH601324S, CWH601385S, CWH601970S, CWH602573S, CWH603036S, CWH603079S, CWH603431S, CWH603434S, CWH603477S, CWH603821S, CWH603840S, CWH603953S, CWH604240S, CWH604483S, CWH604632S, CWH604921S, CWH604975S, CWH605095S, CWH605179S, CWH605357S, CWH605359S, CWH605422S, CWH601010S, CWH601803S, CWH601935S, CWH601972S, CWH602411S, CWH602435S, CWH602708S, CWH602709S, CWH603306S, CWH603642S, CWH604021S, CWH604115S, CWH604160S, CWH604301S, CWH604344S, CWH604451S, CWH604587S, CWH604732S, CWH604811S, CWH604842S, CWH604918S, CWH604946S, CWH605157S, CWH605546S, CWH605547S, CWH604272S, CWH604844S, CWH604866S, CWH605116S, CWH600969S, CWH601002S, CWH601157S, CWH601160S, CWH601166S, CWH601244S, CWH601278S, CWH601297S, CWH601337S, CWH601343S, CWH601371S, CWH601485S, CWH601499S, CWH601787S, CWH601797S, CWH601804S, CWH601829S, CWH601902S, CWH601931S, CWH601968S, CWH602000S, CWH602030S, CWH602034S, CWH602165S, CWH602254S, CWH602270S, CWH602294S, CWH602309S, CWH602329S, CWH602409S, CWH602658S, CWH602743S, CWH602772S, CWH602947S, CWH602949S, CWH603039S, CWH603041S, CWH603062S, CWH603373S, CWH603427S, CWH603487S, CWH603621S, CWH603674S, CWH603720S, CWH603909S, CWH604017S, CWH604196S, CWH604202S, CWH604243S, CWH604323S, CWH604424S, CWH604530S, CWH604647S, CWH604702S, CWH604869S, CWH604880S, CWH604886S, CWH605005S, CWH605012S, CWH605038S, CWH605097S, CWH605119S, CWH605125S, CWH605139S, CWH605220S, CWH605299S, CWH605371S, CWH605392S, CWH605482S, CWH601095S, CWH601327S, CWH601430S, CWH601699S, CWH602245S, CWH602904S, CWH603049S, CWH604749S, CWH604929S, CWH604980S, CWH605502S, CWH603343S, CWH604061S, CWH604857S, CWH605077S, CWH604970S, CWH605362S, CWH602616S, CWH603463S, CWH603499S, CWH603582S, CWH604794S, CWH601692S, CWH601898S, CWH602868S, CWH604853S, CWH605047S, CWH605449S, CWH605472S, CWH601032S, CWH601491S, CWH602701S, CWH602856S, CWH603854S, CWH604774S, CWH605046S, CWH605435S, CWH601850S, CWH602275S, CWH602582S, CWH604015S, CWH604790S, CWH604799S, CWH604695S, CWH605346S, CWH601387S, CWH601695S, CWH601745S, CWH602056S, CWH602288S, CWH602759S, CWH603305S, CWH603492S, CWH603835S, CWH603983S, CWH604341S, CWH604415S, CWH604524S, CWH604583S, CWH604585S, CWH604871S, CWH604883S, CWH604894S, CWH604914S, CWH604955S, CWH605014S, CWH605315S, CWH605408S, CWH605434S, CWH605540S, CWH601784S, CWH601820S, CWH602021S, CWH602639S, CWH602796S, CWH602870S, CWH603485S, CWH604779S, CWH604829S, CWH605303S, CWH605051S, CWH605363S, CWH605541S, CWH604516S, CWH604611S, CWH605013S, CWH601353S, CWH601360S, CWH602163S, CWH602631S, CWH602710S, CWH603042S, CWH603156S, CWH603676S, CWH603829S, CWH604269S, CWH604410S, CWH604613S, CWH604664S, CWH605503S, CWH601502S, CWH602137S, CWH602284S, CWH602591S, CWH603054S, CWH604294S, CWH604904S, CWH605133S, CWH605551S, CWH603307S, CWH603308S, CWH603409S, CWH603657S, CWH603678S, CWH603785S, CWH603803S, CWH604001S, CWH604005S, CWH604013S, CWH604118S, CWH604226S, CWH604268S, CWH604333S, CWH604436S, CWH604438S, CWH604440S, CWH604518S, CWH604548S, CWH604577S, CWH604628S, CWH604629S, CWH604676S, CWH604782S, CWH604784S, CWH604840S
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.