Events

Recall of Device Recall Grollman Pigtail 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
    27749
  • Event Risk Class
    Class 2
  • Event Number
    Z-0159-04
  • Event Initiated Date
    2003-11-05
  • Event Date Posted
    2003-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30461
  • 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
    Angiographic catheter tips may separate during use.
  • Action
    All 7 consignees were contacted by their sales representatives on 11/5-7/2003.

Device

Device Recall Grollman Pigtail Catheter
  • Model / Serial
    Catalog Number 5614-A0, Lot G260778
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, MI, NY, PA, TN, TX. No foreign, government, or military distribution.
  • Product Description
    UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
  • 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