Events

Retiro De Equipo (Recall) de Amphirion Deep OTW PTA Balloon Catheter

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Vascular, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    72502
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0243-2016
  • Fecha de inicio del evento
    2015-10-23
  • Fecha de publicación del evento
    2015-11-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141297
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, percutaneous - Product Code DQY
  • Causa
    Medtronic has discovered that select lots of the amphirion deep pta balloon dilation catheter have a potential breach in the pouch seal enclosing the sterilized product.
  • Acción
    Beginning October 23, 2015, Medtronic will send the customer letter and confirmation form to all identified US customers via 2-day UPS mail delivery. Internationally, communications will be sent per locally approved methods.

Device

Amphirion Deep OTW PTA Balloon Catheter
  • Modelo / Serial
    Model number/lot numbers:  AMD015020002: 209633629; 209882401; 209981044; AMD015020151; 209436628;  AMD015020152; 209821677; 209900858; 210046728 AMD020040002; 209425805; 209601495; 209760077; 209821680; AMD020040152; 209406894;209425802;209471311; 209532785; 209551995;209601496; 209664056; 209759618; 209759619; 209855564; AMD020080002: 209821676; 209855251; 209901400; 210005917; 210046729; AMD020080152: 209436625; 209470469; 209470470; 209532768; 209551997 209760064; 209760065; 209855561; 209900855; AMD020120002; 209722681; 209760093 AMD020120152: 209470465; 209470468; 209532777; 209551996; 209601499 209722674; 209760062; 209760063; 209821673; 209855560; 209900846; 209911605; AMD020150002: 209532784; 209601620; 209664054; 209722667; 209760060; 209981040; 210005913; AMD020150152: 209425766; 209436575; 209509786; 209532790; 209633607; 209664057; 209722685; 209760082; 209855565; 209882402; 209900852; 209911606; 210046730; AMD025040152: 209471307; 209722670; 209821666; 209882403; 209900853; 210046726; AMD025080152; 209406892; 209425768; 209471303; 209509782; 209509783; 209532791; 209601621; 209633611; 209664058; 209760080; 209821679; 209855566; 209882404; 209911600; AMD025120002: 209532776; 209551998; 209760088; AMD025120152: 209470467;209532762; 209664055; 209760069; 209794025; 209882405; 209900851; 209917255; AMD025150002: 209425767; 209553428; 209633606; 209722660; 209760091; 209911603; AMD025150152: 209425771; 209436620; 209470477; 209509781; 209553429; 209633608; 209722663; 209760076; 209900857; 209911517; 210005909; 210046732; AMD030040002: 209821681; AMD030040152: 209471306: 209509785: 209553420; 209601625; 209760061; AMD030080002: 209436579; 209855252; AMD030080152: 209470478; 209532782; 209553421; 209722662; 209759614: 209759615; 209917248; 209981041; 210005915; AMD030120002: 209425806; 209509784; 209601627;209760094 AMD030120152: 209601628; 209722477; 209760068; 209917242; 209981042. AMD030150002: 209530579; 209553422; 209759610; 209759611; 209821674 AMD030150152: 209507756; 209507757; 209633602; 209722678; 209759612; 209759613; 209855257; AMD035040152: 209634197; 209980257; AMD035120002: 209436577; 209553423; AMD035150002: 209633627;  AMD035150152: 209436574; 209633625; 209635221; 209980247; 210046727; AMD040040152: 209425770; 209470473; 209532789; 209553424; 209601629;  209855563; 209900854; AMD040080002: 209436627; AMD040080152: 209601630; 209634198; 209882406; 209980249; 210005903; 210046733; AMD040120002: 209425807; AMD040120152: 209532778; 209601631; 209635220; 209855562; 209911519; 210046725; AMD040150002: 209470464; AMD040150152: 209425763; 209471313; 209532761; 209553425; 209823991; AMD225210002: 209601633; 209722478; 209760078; 209917256; 209980250; 210005904; AMD225210152: 209436626; 209471308; 209532760; 209664048; 209722661; 209760071; 209760072; 209821675; 209855568; 209855569; 209917244; 209917245; 209917246; 209980252; 209980253; 209980254; AMD253210002: 209425769; 209436621; 209532788; 209553426; 209633600; 209722680; 209760070; 209968089; 209981043; 210005912; AMD253210152: 209471301; 209507758; 209509780; 209532771; 209553427; 209633604; 209664051; 209760066; 209760067; 209794020; 209821678; 209882407; 209882408; 209968083; 209968088; 209968091; 209980255; 209980256; 210005914; AMD335210002: 209633603; 209664050; 209760087; 209855567; 209882409; 209968085; AMD335210152; 209470466; 209507754; 209507755; 209633601; 209664049 209760079; 209793539; 209821554; 209855259; 209882410; 209968084; 209968092; 209980259; AMD354210002: 209470475; AMD354210152: 209470474; 209532787; 209633610; 209722475; 209980248; 210005905; AMP015020152: 209471310: 209532780; 209633623; 209722671; 209760084; 209794023; 209900845; AMP020040152: 209436622; 209532772; 209633618; 209722666; 209760074; 209821557; 209900859; AMP020080152: 209425773; 209471314; 209532786; 209633621; 209722677 209821558; 209900850; 209917250; 210006063; AMP020120152: 209470476; 209532765; 209722683; 209821664; 209855254; AMP020150152: 209436576; 209471312; 209532781; 209633620; 209722673; 209760090; 209821672; 209917249; AMP025040152: 209633628; 209760083; 209821667; 209917253 ; AMP025080002: 209633624; AMP025080152: 209471304; 209532774; 209633630; 209821668; 209917247; AMP025120152: 209470472; 209532766; 209633612; 209722679; 209794021; 209917252; 209980258; 210005907; AMP025150152: 209471302; 209722474; 209794022; 210046785;  AMP030040002: 209722672; AMP030040152: 209436578; 209532779; 209633613; 209722668; 209760095; 209821665; 209900856; AMP030080152: 209532769; 209633619; 209722664; 209760089; 209821671; 209917254; 210005919; AMP030120152 : 209471309; 209532773; 209633617; 209722665; 209760086; 209821670; 209882411; AMP030150152: 209436623; 209532764; 209633615; 209722479; 209760085; 209794024; AMP035120152: 209470479; 209633616; 209722676: AMP040040152; 209470471; 209532767; 209633622; 209760081; 209821555; 209882412; 209900844; 209917251; 210006061; AMP040080152: 209821559; 210046724; AMP040120152: 209471315; 209855253; 209882413; 210005918; AMP040150152: 209532775; 209722682; 209821669; 209900847; 210005911; AMP225210152: 209436624; 209471305; 209532763; 209759616; 209759617; 209821660; 209821661; 209821662; 209821663; 209855255; 209855256; 209968082; 209968087; 209968090; 209980251; 210005906; AMP253210152; 209425778; 209471300; 209532770; 209633614; 209664053; 209722675; 209760073; 209821556; 209900849; 210006060; AMP335210152: 209633605; 209722669; 209760096; 209917243; AMP354210152: 209532783; 209760092; 209900848.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia Austria Belgium Brazil China Colombia Costa Rica Czech Republic Denmark Dominican Republic Egypt France Georgia Germany Hong Kong Hungary India Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands Norway Oman Pakistan Panama Peru Philippines Poland Portugal Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syria Taiwan Thailand Trinidad and Tobago Turkey United Arab Emirates United Kingdom and Uruguay. .
  • Descripción del producto
    Amphirion Deep OTW PTA Balloon Catheter: || Model numbers: || US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080152 AMP253210152 AMP020080152 AMP025080002 AMP030040002 AMP030150152 AMP040120152 AMP335210152 AMP020120152 AMP025080152 AMP030040152 AMP035120152 AMP040150152 AMP354210152; || OUS: || AMD025150152 AMD030150152 AMD040120002 AMD335210002 || AMD030040002 AMD035040152 AMD040120152 AMD335210152 || AMD030040152 AMD035120002 AMD040150002 AMD354210002 || AMD030080002 AMD035150002 AMD040150152 AMD354210152 || AMD030080152 AMD035150152 AMD225210002 || AMD030120002 AMD040040152 AMD225210152 || AMD030120152 AMD040080002 AMD253210002 || AMD030150002 AMD040080152 AMD253210152 || Cardiovascular: Intended for use in Angioplasty
  • Manufacturer
    Medtronic Vascular, Inc.

Manufacturer

Medtronic Vascular, Inc.
  • Dirección del fabricante
    Medtronic Vascular, Inc., 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA