Events

Recall of Device Recall Performa Cardiac Multipack

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
    65150
  • Event Risk Class
    Class 2
  • Event Number
    Z-1408-2013
  • Event Initiated Date
    2013-05-02
  • Event Date Posted
    2013-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118029
  • 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
    Merit medical systems is recalling various lots of performa cardiac multipacks containing a jr4.0 catheter due to a slight variation in tip shape.
  • Action
    Merit sent an Urgent Product Recall Notice letter dated May 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to identify, quarantine, discontinue using products, and contact their sales representative to arrange product return and replacement or credit. For questions call 1-801-208-4468.

Device

Device Recall Performa Cardiac Multipack
  • Model / Serial
    Lot Numbers: 1662386, 1662390, 1662385, 1662387, 1662391
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution.
  • Product Description
    Merit Medical PerfOrma Anglographic Catheter 5F Multipack || Product Usage: || Angiographic catheters are 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