Events

Retiro De Equipo (Recall) de Device Recall Sizing Balloon II

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 AGA Medical Corporation.

¿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
    57819
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1595-2011
  • Fecha de inicio del evento
    2010-12-17
  • Fecha de publicación del evento
    2011-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97502
  • 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, intravascular occluding, temporary - Product Code MJN
  • Causa
    Aga medical is initiating a voluntary recall of a specific lot of mislabeled amplatzer sizing balloon ii. aga medical received 2 reports from customers who received sizing balloons that were labeled as 34 mm; however, the package contained 24 mm devices. the proper sizing (24 mm) was printed on the device hub visible through the product package.
  • Acción
    AGA Medical Corporation sent an Urgent Medical Device Voluntary Recall letter, dated December 17, 2010, via e-mail to all affected customers. A hard copy was sent via Fed Ex to customers on December 20, 2010. The letter identified the product, described the issue, and the action that should be taken by the customer. Customers were requested to cease distribution and use of the devices, check inventory for unused devices, and complete and return a response form to facilitate return of the affected devices to AGA. For questions regarding this recall call 1-763-531-3175.

Device

Device Recall Sizing Balloon II
  • Modelo / Serial
    Lot 10004282114
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AZ, CA, KY, PA, SC, TX and OUS to include: Argentina, Germany, Greece, Netherlands, Peru, Poland, Portugal, Slovakia, United Kingdom
  • Descripción del producto
    AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane North, Plymouth, MN 55442. || The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Dirección del fabricante
    AGA Medical Corporation, 5050 Nathan Ln N, Plymouth MN 55442-3209
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA