Events

Recall of ReShape

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
    75475
  • Event Risk Class
    Class 2
  • Event Number
    Z-0392-2017
  • Event Initiated Date
    2016-10-14
  • Event Date Posted
    2016-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150463
  • 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
    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
  • Model / Serial
    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
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of: MO, TX, AZ, CA, NY, TN, GA, LA, FL, MA, OH, IN, IL
  • Product Description
    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
  • Manufacturer Address
    Reshape Medical Inc, 100 Calle Iglesia, San Clemente CA 92672-7502
  • Source
    USFDA