Events

Rappel de ReShape

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Reshape Medical Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75475
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0392-2017
  • Date de mise en oeuvre de l'événement
    2016-10-14
  • Date de publication de l'événement
    2016-11-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150463
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Implant, intragastric for morbid obesity - Product Code LTI
  • Cause
    Reshape medical is recalling the integrated dual balloon system gen 1 due to the potential leak of distillation fluid during balloon inflation.
  • Action
    ReShape sent a customer notification letter dated October 14, 2016 was sent to customers to inform them that ReShape Medical is recalling the Integrated Dual Balloon System due to customer reports of instillation fluid leaking during the device inflation procedure. The letter informs the customers that any instillation fluid leakage during the inflation process will cause an incomplete balloon fill and require immediate removal of the device. Customers are instructed to contact ReShape Medical Customer Service at (844) 9377374 for any questions related to the product returns.

Device

ReShape
  • Modèle / numéro de série
    Lot Number Expiration Date 160815-001 2018-08-07 160816-001 2018-08-07 160824-003 2018-08-18 160825-001 2018-08-18 160825-002 2018-08-18
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL
  • Description du dispositif
    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 || product Usage: || 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 obesityrelated 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
  • Adresse du fabricant
    Reshape Medical Inc, 100 Calle Iglesia, San Clemente CA 92672-7502
  • Source
    USFDA