Events

Recall of Device Recall Mistique Infusion Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merit Medical Systems, 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
    54228
  • Event Risk Class
    Class 2
  • Event Number
    Z-0892-2010
  • Event Initiated Date
    2010-01-06
  • Event Date Posted
    2010-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87909
  • 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
    Continuous Flush Catheter - Product Code KRA
  • Reason
    Infusion catheters may become brittle and break during use.
  • Action
    All affected sales reps were notified by phone and a Mistique Infusion Catheter - Product Recall letter on 01/06/2010 and instructed to contact their accounts, inform them of the recall situation, and complete the Recall Notification form with a site representative. Accounts were to immediately cease use of any affected units and to arrange for return to Merit. Recall actions are to be completed by Jan 22, 2010. Questions should be directed to Greg Turner at 801-316-4998 or Liz Pratt at 801-208-4828.

Device

Device Recall Mistique Infusion Catheter
  • Model / Serial
    Lot Numbers: F725685, F613221, F682088, F717755, F651484, F515919, F525522, F616416, F586945, F598771, F568275, F586078, F598764, F601954, F630041, F638412, F645779, and F758857.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AL, CA, IN, LA, MO, MS, NC, NY, OH, PA, SC, UT, and VA and countries of India, Japan, Poland, San Marino, and UK.
  • Product Description
    Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 || Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Manufacturer Parent Company (2017)
    Merit Medical Systems Inc
  • Source
    USFDA