Events

Retiro De Equipo (Recall) de Device Recall Boston Scientific Soloist

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
    61377
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1319-2012
  • Fecha de inicio del evento
    2012-03-02
  • Fecha de publicación del evento
    2012-03-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107941
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    Device found labeled with the incorrect expiration dates. the soloist single needle electrode has been qualified for a 3 year expiration date. product manufactured between the dates of may 24, 2011 and november 8, 2011 has an incorrect expiration date of 20 years labeled on the pouched needle electrode and 5 years labeled on the carton.
  • Acción
    Boston Scientific sent a Urgent Medical Device Recall letter dated March 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed to cease use, quarantine and return unused product with directions to forward the notification to the hospital level. Customers were directed to fill out the Reply Verification Tracking Form and fax to 508¿683¿5578, for reimbursement. Returned goods are to be sent to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 We regret any inconvenience that this action may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. For further questions please call (508) 683-4678.

Device

Device Recall Boston Scientific Soloist
  • Modelo / Serial
    Soloist Single Needle M001262500 Reference Inner 14386589, 14435130, 14578709, 14629530, 14715963, Electrode -18cm (outer pouch Information) 14722621, 14776399, 14805361 box)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) and the countries of Canada, Columbia, Viet Nam, Germany, France, Great Britain, Italy, Jordan, Kuwait, Netherlands Pakistan, Portugal, S. Arabia, Slovakia, Spain, Sweden and Tunisia.
  • Descripción del producto
    Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. || The Soloist Needle Electrode is intended for use in conjunction with a Boston Scientific Corporation radiofrequency. (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
  • 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