Events

Retiro De Equipo (Recall) de Device Recall ReShape Integrated Dual Balloon System, Gen 1

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 Reshape Medical 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
    74781
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2552-2016
  • Fecha de inicio del evento
    2016-05-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148437
  • 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
    Implant, intragastric for morbid obesity - Product Code LTI
  • Causa
    Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. the possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure.
  • Acción
    A Dear Doctor letter dated May 4, 2016, was sent to all the customers to inform them that ReShape Medical is recalling ReShape Integrated Dual Balloon System, Gen 1 due to a suspected misalignment of the connection between the proximal balloon cap and the delivery catheter. The letter informs the customers that the possible misalignment is the result of an assembly error during manufacturing and may lead to leakage of saline solution during the balloon inflation procedure. Customers are informed of the planned field correction and if customers have any questions then they're instructed to contact ReShape Medical Customer Service at (844) 937-7374. For further questions please call (949) 429-6680 ext. 106

Device

Device Recall ReShape Integrated Dual Balloon System, Gen 1
  • Modelo / Serial
    160317-001, 160371-002, 160317-003, 160324-010.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US: Distribution to the states of : NY, OH and CA.
  • Descripción del producto
    ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 || The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
  • Manufacturer
    Reshape Medical Inc

Manufacturer

Reshape Medical Inc
  • Dirección del fabricante
    Reshape Medical Inc, 100 Calle Iglesia, San Clemente CA 92672-7502
  • Source
    USFDA