Events

Recall of Device Recall ReShape Integrated Dual Balloon System, Gen 1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Reshape Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74781
  • Event Risk Class
    Class 2
  • Event Number
    Z-2552-2016
  • Event Initiated Date
    2016-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148437
  • Notes / Alerts
    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.
  • Extra notes in the data
    Implant, intragastric for morbid obesity - Product Code LTI
  • Reason
    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.
  • Action
    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
  • Model / Serial
    160317-001, 160371-002, 160317-003, 160324-010.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US: Distribution to the states of : NY, OH and CA.
  • Product Description
    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
  • Manufacturer Address
    Reshape Medical Inc, 100 Calle Iglesia, San Clemente CA 92672-7502
  • Source
    USFDA