Events

Recall of Device Recall Maestro Microcatheter

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
    67128
  • Event Risk Class
    Class 2
  • Event Number
    Z-0614-2014
  • Event Initiated Date
    2013-12-06
  • Event Date Posted
    2013-12-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124756
  • 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, continuous flush - Product Code KRA
  • Reason
    Merit medical systems, inc. is conducting a recall for 3 lots of maestro microcatheters with a graphic discrepancy on the carton/box label end panel. the catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.
  • Action
    Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062. For questions regarding this recall call 801-253-1600.

Device

Device Recall Maestro Microcatheter
  • Model / Serial
    Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • Product Description
    Catheter, Continuous Flush || The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
  • 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