Events

Recall of NxStage

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NxStage 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
    72554
  • Event Risk Class
    Class 2
  • Event Number
    Z-0337-2016
  • Event Initiated Date
    2015-10-29
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141528
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Reason
    Ultrafiltration volume (ufv) may not decrease during treatment-software error. the uf pump may continue to run and remove fluid even after the target uf volume has been removed.
  • Action
    NxStage issued a Field Safety Notice (FSN), dated October 29, 2015, to clinic and home patients with a NX1000-3 or NX1000-4 cycler. For patients performing short daily hemodialysis, the FSN included instructions for steps to be taken so that the cycler and treatments are not affected by the software error. Patients performing nocturnal hemodialysis were instructed to contact their Center for a replacement NX1000-1 Cycler. A software update will be released to correct the error. Customers should complete and return the reply form. Contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243) with questions or comments.

Device

NxStage
  • Model / Serial
    Software version 4.9 and 4.10
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    NxStage System One S Cycler -High Permeability Hemodialysis System || Model no. NX1000-4
  • Manufacturer
    NxStage Medical, Inc.

Manufacturer

NxStage Medical, Inc.
  • Manufacturer Address
    NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
  • Manufacturer Parent Company (2017)
    Nxstage Medical Inc
  • Source
    USFDA