FDAFDA · Alimentos y medicamentos·N.º oficial Z-1729-2023
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; 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 00643169720312, Lot Serial Numbers: BLF258142H, BLF257918H, BLF258186H, BLF258209H, BLF257508H, BLF258084H, BLF257081H, BLF257089H, BLF257260H, BLF257290H, BLF257410H, BLF257440H, BLF257565H, BLF257668H, BLF257684H, BLF257873H, BLF257966H, BLF256897H, BLF257648H, BLF256756H, BLF256776H, BLF256865H, BLF257835H, BLF257086H, BLF257198H, BLF257413H, BLF257605H, BLF257611H, BLF257863H, BLF257960H, BLF257342H, BLF257460H, BLF257657H, BLF256948H, BLF257877H, BLF256848H, BLF257404H, BLF257931H, BLF257961H, BLF258043H, BLF258080H, BLF257904H, BLF257104H, BLF257029H, BLF257408H, BLF257431H, BLF257388H, BLF257618H, BLF257916H, BLF257972H, BLF256843H, BLF256844H, BLF256971H, BLF257125H, BLF257347H, BLF258090H, BLF257677H, BLF258051H, BLF257844H, BLF257627H, BLF257348H, BLF258261H, BLF257215H, BLF257468H, BLF256758H, BLF257803H, BLF258143H, BLF257449H, BLF257885H, BLF257899H, BLF257956H, BLF258078H, BLF258093H, BLF258094H, BLF258178H, BLF258228H, BLF257037H, BLF257384H, BLF258292H, BLF257430H, BLF257459H, BLF256911H, BLF256979H, BLF256984H, BLF256999H, BLF257398H, BLF257568H, BLF257682H, BLF258129H, BLF258141H, BLF258202H, BLF258219H, BLF258236H, BLF258294H, BLF256867H, BLF257276H, BLF258268H, BLF256968H, BLF256969H, BLF257429H, BLF257843H, BLF257437H, BLF257532H, BLF257054H, BLF257651H, BLF256785H, BLF256799H, BLF257456H, BLF258254H, BLF256780H, BLF257014H, BLF258185H, BLF256985H, BLF257147H, BLF257832H, BLF257606H, BLF257866H, BLF256874H, BLF256883H, BLF257230H, BLF257253H, BLF257636H, BLF257807H, BLF257868H, BLF257927H, BLF257933H, BLF257986H, BLF258140H, BLF258169H, BLF258199H, BLF258239H, BLF258250H, BLF255363H, BLF257634H, BLF257639H, BLF257780H, BLF257781H, BLF257782H, BLF257785H, BLF257787H, BLF257788H, BLF257791H, BLF257794H, BLF257879H, BLF258289H, BLF258291H, BLF257350H, BLF256962H, BLF257401H, BLF258055H, BLF256900H, BLF257394H, BLF257746H, BLF258172H, BLF258041H, BLF257615H, BLF258180H, BLF256995H, BLF257576H, BLF258040H, BLF256915H, BLF258159H, BLF257279H, BLF257826H, BLF257968H, BLF258069H, BLF258072H, BLF258276H, BLF257139H, BLF257614H, BLF257470H, BLF257630H, BLF258074H, BLF258106H, BLF258170H, BLF257012H, BLF257155H, BLF258057H, BLF258066H, BLF257530H, BLF257025H, BLF257422H, BLF257487H, BLF257525H, BLF257550H, BLF257864H, BLF257203H, BLF256828H, BLF257035H, BLF257343H, BLF257091H, BLF258295H, BLF257423H, BLF257213H, BLF257397H, BLF257604H, BLF257823H, BLF258011H, BLF257173H, BLF257291H, BLF257386H, BLF257678H, BLF257755H, BLF257773H, BLF257867H, BLF257997H, BLF258076H, BLF258183H, BLF257502H, BLF257420H, BLF256841H, BLF258088H, BLF257092H, BLF257482H, BLF257195H, BLF257529H, BLF257099H, BLF257171H, BLF257617H, BLF257583H, BLF257999H, BLF256870H, BLF256931H, BLF256936H, BLF256965H, BLF257024H, BLF257132H, BLF257144H, BLF257150H, BLF257151H, BLF257152H, BLF257177H, BLF257360H, BLF257395H, BLF257523H, BLF257620H, BLF257642H, BLF257676H, BLF258022H, BLF258060H, BLF258191H, BLF258211H, BLF258213H, BLF258214H, BLF258222H, BLF257824H, BLF258052H, BLF257747H, BLF256906H, BLF257009H, BLF257245H, BLF257352H, BLF257596H, BLF258085H, BLF258260H, BLF257122H, BLF256789H, BLF256833H, BLF256869H, BLF257149H, BLF258139H, BLF257137H, BLF257071H, BLF257157H, BLF257560H, BLF257856H, BLF257910H, BLF257356H, BLF257865H, BLF257875H, BLF257993H, BLF256860H, BLF257409H, BLF257504H, BLF256767H, BLF257601H, BLF256959H, BLF257383H, BLF257450H, BLF257998H, BLF258083H, BLF257141H, BLF257286H, BLF257675H, BLF257498H, BLF256757H, BLF257134H, BLF257180H, BLF257436H, BLF257480H, BLF256845H, BLF256961H, BLF257322H, BLF257370H, BLF257507H, BLF257512H, BLF257762H, BLF258008H, BLF258009H, BLF258184H, BLF256877H, BLF256950H, BLF257027H, BLF256857H, BLF256960H, BLF256829H, BLF257369H, BLF257060H, BLF258131H, BLF257234H, BLF257248H, BLF257389H, BLF257696H, BLF257901H, BLF257233H, BLF258103H, BLF256991H, BLF257490H, BLF257632H, BLF258152H, BLF256891H, BLF257156H, BLF257907H, BLF257987H, BLF256909H, BLF257250H, BLF256849H, BLF256769H, BLF257351H, BLF257411H
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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