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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1817-2023

ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; 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 00763000001629, Lot Serial Numbers: CWR601226S, CWR601747S, CWR614516S, CWR615056S, CWR611693S, CWR610177S, CWR613808S, CWR600732S, CWR606430S, CWR602651S, CWR607356S, CWR610310S, CWR604045S, CWR603303S, CWR609623S, CWR605872S, CWR601687S, CWR603211S, CWR602807S, CWR607694S, CWR613692S, CWR613696S, CWR605094S, CWR610428S, CWR606832S, CWR607019S, CWR612869S, CWR614166S, CWR614552S, CWR608782S, CWR611713S, CWR614839S, CWR613888S, CWR614119S, CWR614102S, CWR614110S, CWR613089S, CWR612399S, CWR608766S, CWR614937S, CWR612224S, CWR614130S, CWR612786S, CWR614153S, CWR613324S, CWR612299S, CWR612283S, CWR612754S, CWR610251S, CWR610659S, CWR604739S, CWR605422S, CWR605753S, CWR606253S, CWR607872S, CWR609650S, CWR613342S, CWR606875S, CWR601224S, CWR601549S, CWR601550S, CWR602194S, CWR603281S, CWR603711S, CWR604836S, CWR605024S, CWR605378S, CWR606857S, CWR609093S, CWR600564S, CWR601374S, CWR601412S, CWR602016S, CWR602048S, CWR602172S, CWR602215S, CWR602229S, CWR602850S, CWR604727S, CWR604841S, CWR605233S, CWR605740S, CWR606077S, CWR606621S, CWR607419S, CWR607905S, CWR609837S, CWR609987S, CWR610588S, CWR611070S, CWR611189S, CWR611604S, CWR611683S, CWR613086S, CWR614108S, CWR614126S, CWR614582S, CWR600290S, CWR600798S, CWR600903S, CWR601809S, CWR601823S, CWR602693S, CWR600201S, CWR600280S, CWR600780S, CWR601028S, CWR601781S, CWR602187S, CWR602514S, CWR602565S, CWR602736S, CWR602986S, CWR603209S, CWR605149S, CWR605488S, CWR605758S, CWR605886S, CWR606853S, CWR608265S, CWR609492S, CWR610199S, CWR612442S, CWR614545S, CWR600252S, CWR600345S, CWR600458S, CWR600856S, CWR600956S, CWR601014S, CWR601183S, CWR601314S, CWR601340S, CWR601732S, CWR602038S, CWR602235S, CWR602603S, CWR602654S, CWR602806S, CWR603666S, CWR604043S, CWR604120S, CWR604188S, CWR604327S, CWR604432S, CWR604449S, CWR604644S, CWR604786S, CWR604927S, CWR605399S, CWR605686S, CWR606156S, CWR606532S, CWR607809S, CWR608344S, CWR609044S, CWR609654S, CWR609994S, CWR610033S, CWR610060S, CWR611609S, CWR613391S, CWR605551S, CWR606629S, CWR613929S, CWR603068S, CWR607842S, CWR603790S, CWR601032S, CWR605418S, CWR609662S, CWR605721S, CWR606821S, CWR606822S, CWR606823S, CWR607445S, CWR608012S, CWR608676S, CWR609127S, CWR609856S, CWR610013S, CWR610081S, CWR610661S, CWR611612S, CWR611656S, CWR611792S, CWR611829S, CWR611830S, CWR612737S, CWR613107S, CWR613921S, CWR601481S, CWR600288S, CWR600689S, CWR600934S, CWR602186S, CWR602262S, CWR602399S, CWR602543S, CWR602748S, CWR603069S, CWR603513S, CWR603871S, CWR604261S, CWR605516S, CWR607379S, CWR608894S, CWR600461S, CWR609853S, CWR600257S, CWR600508S, CWR600596S, CWR600971S, CWR600992S, CWR601188S, CWR601701S, CWR601876S, CWR602066S, CWR602577S, CWR603241S, CWR600924S, CWR601211S, CWR606867S, CWR608868S, CWR610123S, CWR602914S, CWR602915S, CWR602916S, CWR602918S, CWR602919S, CWR602920S, CWR600366S, CWR600483S, CWR600561S, CWR601472S, CWR601813S, CWR601851S, CWR601872S, CWR602073S, CWR602110S, CWR602204S, CWR602264S, CWR602272S, CWR602422S, CWR602632S, CWR602747S, CWR602766S, CWR602780S, CWR602781S, CWR603010S, CWR603057S, CWR603060S, CWR603257S, CWR603332S, CWR603343S, CWR603412S, CWR603911S, CWR604051S, CWR604095S, CWR604281S, CWR604392S, CWR604768S, CWR604902S, CWR605022S, CWR605137S, CWR605746S, CWR605866S, CWR605965S, CWR606110S, CWR606112S, CWR606134S, CWR606280S, CWR606556S, CWR606816S, CWR607155S, CWR607488S, CWR607813S, CWR607824S, CWR608173S, CWR608235S, CWR608671S, CWR608852S, CWR609020S, CWR609021S, CWR609222S, CWR609818S, CWR609868S, CWR610399S, CWR610689S, CWR610890S, CWR612533S, CWR612748S, CWR612793S, CWR612836S, CWR613094S, CWR613100S, CWR613116S, CWR613118S, CWR613402S, CWR613922S, CWR613966S, CWR614157S, CWR614501S, CWR600514S, CWR601793S, CWR602944S, CWR604084S, CWR604255S, CWR604523S, CWR605092S, CWR606677S, CWR608373S, CWR609858S, CWR610070S, CWR612488S, CWR613954S, CWR602815S, CWR604794S, CWR605392S, CWR605394S, CWR605841S, CWR606033S, CWR606652S, CWR607177S, CWR607485S, CWR608661S, CWR609003S, CWR611127S, CWR612100S, CWR611728S
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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