Events

Recall of Device Recall Dilator for percutaneous catheterization.

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
    29651
  • Event Risk Class
    Class 2
  • Event Number
    Z-1310-04
  • Event Initiated Date
    2004-07-20
  • Event Date Posted
    2004-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34288
  • 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
    Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
  • Reason
    Firm received a report of an introducer sheath separating from its hub while in the patient. surgery was successful in removal, even though the sheath kept breaking during the attempt.
  • Action
    Consignees were notified by phone and letter on 7/20/2004.

Device

Device Recall Dilator for percutaneous catheterization.
  • Model / Serial
    Catalog Number MAK401N, Lot Numbers: G331723, G338460, M9337635, MR314388, MR317166, MR320063.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.
  • Product Description
    Merit MAK Mini Access Kit, 4 French (1.3mm)
  • Manufacturer
    Merit Medical Systems, Inc

Manufacturer

Merit Medical Systems, Inc
  • Manufacturer Address
    Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA