Events

Recall of Device Recall Millar disposable angiographic catheter (Left Heart)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Millar Instruments, 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
    58123
  • Event Risk Class
    Class 1
  • Event Number
    Z-1725-2011
  • Event Initiated Date
    2011-03-08
  • Event Date Posted
    2011-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98428
  • 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, intravascular, diagnostic - Product Code DQO
  • Reason
    Possibility of epoxy debris particles inside the catheter lumen.
  • Action
    The firm, Millar, notified their consignees/customers by email and sent hardcopy of email on March 8, 2011. The notification described the product, problem and actions to be taken. The customers were instructed to return the catheter(s) to Millar or report back to Millar if the catheter(s) has been consumed. If you have any questions, please do not hesitate to contact Director, RA/QA at 832-667-7000.

Device

Device Recall Millar disposable angiographic catheter (Left Heart)
  • Model / Serial
    800-4219-1 and 800-4219-3 Listing #: D055900 and D055901
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN, NY, Washington DC, NC, MA, MN, PA, CA, MI, Australia, Germany, Canada, Japan, United Kingdom, and Norway.
  • Product Description
    Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F. || Provide intravascular pressure readings and capability for the deliverance of high-speed injection of radiopaque contrast media used in vascular imaging to selected sites in the vascular system.
  • Manufacturer
    Millar Instruments, Inc

Manufacturer

Millar Instruments, Inc
  • Manufacturer Address
    Millar Instruments, Inc, 6001-A Gulf Fwy, Houston TX 77023
  • Source
    USFDA