Events

Recall of SoftVu Omni Flush Angiographic Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics, 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
    79193
  • Event Risk Class
    Class 2
  • Event Number
    Z-0742-2018
  • Event Initiated Date
    2017-09-22
  • Event Date Posted
    2018-02-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161576
  • 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
    Product was placed into distribution prior to completion of all required post sterilization release activities.
  • Action
    Consignees were contacted by phone and by a letter sent via Federal Express. Consignees were instructed to stop using product, segregate affected product, and return the product to the firm along with a reply verification tracking form. For further questions, please call (518) 795-1676.

Device

SoftVu Omni Flush Angiographic Catheter
  • Model / Serial
    Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
  • Product Description
    Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 || AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA