Events

Recall of Device Recall Vessel Sizing Angiographic 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
    55661
  • Event Risk Class
    Class 2
  • Event Number
    Z-1731-2010
  • Event Initiated Date
    2010-05-05
  • Event Date Posted
    2010-05-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91473
  • 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
    Marker bands on angiographic catheters may not be properly attached, allowing movement of the bands.
  • Action
    Merit Medical Systems, Inc. began notifying sales representatives beginning May 5, 2010 via phone and instructed to contact all of their affected accounts. All affected product was to be returned to the firm. For further information, contact Merit Medical at 1-713-757-5067 or 1-801-208-4468.

Device

Device Recall Vessel Sizing Angiographic Catheter
  • Model / Serial
    Lot Number: G775032
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- GA, IL, MO, NY, PA and WI.
  • Product Description
    Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. || Designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
  • 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