Events

Recall of NAMIC Custom Angiographic Kit, Left Heart Kit.

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

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
    30489
  • Event Risk Class
    Class 2
  • Event Number
    Z-0303-05
  • Event Initiated Date
    2004-10-21
  • Event Date Posted
    2004-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35997
  • 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
    Needle, Hypodermic, Single Lumen - Product Code FMI
  • Reason
    The kits contains defective magellan monoject safety needles. the needle shaft may separate from the hub. tyco healthcare has recalled the needles.
  • Action
    Two customers contacted via phone on 10/21/04 and 10/22/04, followed by letters dated 11/17/2004. Customers instructed to discontinue use and return product. Distributor instructed to notify customers.

Device

NAMIC Custom Angiographic Kit, Left Heart Kit.
  • Model / Serial
    988046
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    2 customers in IL and NV.
  • Product Description
    NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Manufacturer Address
    Boston Scientific Corp, 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Source
    USFDA