Events

Recall of Device Recall NovaGold

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NEO METRICS, 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
    68279
  • Event Risk Class
    Class 2
  • Event Number
    Z-1747-2014
  • Event Initiated Date
    2014-03-31
  • Event Date Posted
    2014-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127263
  • 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
    Endoscopic guidewire, gastroenterology-urology - Product Code OCY
  • Reason
    Neo metrics, inc. is recalling novagold guidewire because the tip may uncoil and / detach more frequently than anticipated. there have been no reports of illness or injury.
  • Action
    NeoMetrics sent a letter dated March 31, 2014, to Boston Scientific. On March 24, 2014, Boston Scientific made NeoMetrics aware that Boston Scientific received 3 complaints from customers that the tip of the NovaGold guidewire detached and/or became uncoiled. Because the tips are breaking and/or uncoiling at a rate that was not anticipated, it has been decided that these units should be removed from the field. Therefore, NeoMetrics does not object to Boston Scientific executing this product removal in accordance with Section 4.4 of the distribution agreement. For further questions please call (763) 559-4440.

Device

Device Recall NovaGold
  • Model / Serial
    MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.
  • Product Description
    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. || The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
  • Manufacturer
    NEO METRICS, INC.

Manufacturer

NEO METRICS, INC.
  • Manufacturer Address
    NEO METRICS, INC., 2605 Fernbrook Ln N Ste J, Plymouth MN 55447-4756
  • Manufacturer Parent Company (2017)
    Einhorn Verwaltungsges. Mbh
  • Source
    USFDA