Events

Recall of Device Recall Strata II / Strata NSC valves

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

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
    76249
  • Event Risk Class
    Class 2
  • Event Number
    Z-1121-2017
  • Event Initiated Date
    2017-01-17
  • Event Date Posted
    2017-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152582
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Reason
    Medtronic neurosurgery initiated a recall after receiving five (5) product experiences between february 15, 2015 and august 23, 2016 reporting of discrepancies between the pressure/performance level (pl) at which the valve was set and the readings determined via an x-ray image.
  • Action
    Medtronic sent an Urgent Product Advisory Notice dated January 19, 2017, was sent to customers to inform them that Medtronic Neurosurgery is initiating a voluntary field corrective action (FCA) for the Medtronic Strata II / Strata NSC valves (includes Burr Hole and Lumboperitoneal. Excludes StrataMR). Medtronic is notifying healthcare providers of an Instructions For Use (IFU) Warning update for the affected products by sending a Product Advisory Notice. For further questions regarding this recall please call (805) 571-8400..

Device

Device Recall Strata II / Strata NSC valves
  • Model / Serial
    All Lot Numbers
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Algeria India Poland Armenia Indonesia Portugal Australia Iran Austria Iraq Qatar Bangladesh Ireland Republic of Montenegro Barbados Israel Republic of Serbia Belarus Italy Romania Belgium Jamaica Russian Federation Bosnia and Herzegovina Japan Saudi Arabia Botswana Jordan Singapore Bulgaria Kazakhstan Slovakia Cambodia Kenya South Africa Canada Kuwait South Korea Canary Islands Latvia Spain Cayman Islands Lebanon Sri Lanka China Libya Sweden Croatia Lithuania Switzerland Cyprus Macau Syria
  • Product Description
    Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. || Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism. || Strata Valve Magnet Reverse Polarity (Excludes StrataMR). || Catalog No. || 27739 || 27740 || 27786 || 27787 || 27788 || 27789 || 27794 || 27812 || 27814 || 27815 || 27816 || 27817 || 27818 || 27820 || 27821 || 27822 || 27823 || 27824 || 27825 || 27827 || 27828 || 27830 || 27831 || 27832 || 27848 || 27864 || 27867 || 27868 || 27888 || 27903 || 27922 || 27823 || 27924 || 23042 || 27925 || 27926 || 27927 || 27932 || 27933 || 42335 || 42355 || 42365 || 42836 || 42856 || 42866 || 44420 || 44421 || 44430 || 44465 || 46070 || 46075 || 46080 || 46085 || 46635 || 46655 || 46665 || 46836 || 46856 || 46866 || 46871 || 46876 || 46881 || 46886 || 92355 || 92365 || 92856 || 92866 || 96655 || 96665
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • Manufacturer Address
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-3083
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA