Events

Retiro De Equipo (Recall) de Device Recall Boston Scientific Imager II Angiographic 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 Boston Scientific 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
    76772
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2645-2017
  • Fecha de inicio del evento
    2016-12-15
  • Fecha de publicación del evento
    2017-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154140
  • 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, diagnostic - Product Code DQO
  • Causa
    A field report indicated some units within this lot were missing the bottom pouch seal. the compromised seal is completely missing and is obvious to the user.
  • Acción
    Customers were sent an Urgent Medical Device Removal letter, dated 12/15/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or BSCFieldActionCenter@bsci.com

Device

Device Recall Boston Scientific Imager II Angiographic Catheter
  • Modelo / Serial
    Lot: 00112758, Use by 2018-05-11
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    CA, FL, KY, MO, NM, OK, OR, PA, and TX.
  • Descripción del producto
    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 2 Scimed Pl, Maple Grove MN 55311-1565
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA