Events

Retiro De Equipo (Recall) de Extractor Pro RX

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
    71137
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1941-2015
  • Fecha de inicio del evento
    2015-04-27
  • Fecha de publicación del evento
    2015-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136204
  • 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, biliary, diagnostic - Product Code FGE
  • Causa
    One lot of the extractor" pro rx retrieval balloon catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
  • Acción
    Boston Scientific sent an Urgent Medical Device Recall Removal letter dated April 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected product in their inventory, quarantine the affected product immediately and return to Boston Scientific in accordance with the enclosed recall instructions. Customers will receive replacements for all recalled product that is returned to Boston Scientific. Customers were instructed to forward the recall notification to their customers. Customers with questions were instructed to contact their local sales representative. For questons regarding this recall call 763-494-1133.

Device

Extractor Pro RX
  • Modelo / Serial
    Lot: 17673858
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
  • Descripción del producto
    Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 || The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • 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