Events

Recall of Device Recall EndoVive 3s Low Profile Balloon Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Xeridiem Mediem Medical Devices 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
    73024
  • Event Risk Class
    Class 2
  • Event Number
    Z-0997-2016
  • Event Initiated Date
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142973
  • 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
    Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
  • Reason
    A feeding (reflux) valve leakage issue. the feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the low profile balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.
  • Action
    Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customer was provided the following instructions: 1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users. 2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users. For any questions the customers is instructed to contact the firm. For questions regarding this recall call 520-882-7794.

Device

Device Recall EndoVive 3s Low Profile Balloon Kits
  • Model / Serial
    Part Number: M00549430 (XMD P/N 70-0050-D22)  Lot Number: 930149
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to MA only.
  • Product Description
    EndoVive 3s Low Profile Balloon Kits || Part Number: || M00549430 || (XMD P/N 70-0050-D22) || The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
  • Manufacturer
    Xeridiem Mediem Medical Devices Inc

Manufacturer

Xeridiem Mediem Medical Devices Inc
  • Manufacturer Address
    Xeridiem Mediem Medical Devices Inc, 4700 S Overland Dr, Tucson AZ 85714-3430
  • Source
    USFDA