Events

Recall of Device Recall 7 cm Catheter Reservoir with 10 cm extension

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

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
    32533
  • Event Risk Class
    Class 3
  • Event Number
    Z-0366-06
  • Event Initiated Date
    2005-03-24
  • Event Date Posted
    2006-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40284
  • 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
    Catheter, Ventricular - Product Code HCA
  • Reason
    Stylet in package is shorter than that claimed on the label.
  • Action
    The recalling firm issued a letter to their customers informing them of the problem and the need to return the product.

Device

Device Recall 7 cm Catheter Reservoir with 10 cm extension
  • Model / Serial
    M1330/PR07X/11-2009 and M1476/PR07X/12-2009
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to a hospital in CA and a distributor in Germany.
  • Product Description
    7 cm Catheter Reservoir with 10 cm extension
  • Manufacturer
    Vygon Neuro

Manufacturer

Vygon Neuro
  • Manufacturer Address
    Vygon Neuro, 2495 General Armistead Ave, Norristown PA 19403-3685
  • Source
    USFDA