Events

Recall of Device Recall Profiler Balloon Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Angiodynamics Worldwide Headquarters.

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
    59831
  • Event Risk Class
    Class 2
  • Event Number
    Z-3261-2011
  • Event Initiated Date
    2011-02-25
  • Event Date Posted
    2011-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103829
  • 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
    Percutaneous Catheter - Product Code DQY
  • Reason
    The particular lots of profiler pta balloon catheters were labeled incorrectly. lot 532109 contains product that is actually 5 mm x 4 cm x 40 cm and lot 532794 contains product that is actually 4 mm x 2 cm x 40 cm.
  • Action
    Angiodynamics, Inc sent a "Urgent Medical Device Recall letter" dated February 25, 2011 to all affected customers via Certified Mail Return Receipt Requested. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed the following steps 1. Identify and segregate the recalled lot that is in your possession. 2. Complete the enclosed Profiler PTA Balloon Catheter Recall Reply Form and fax it to the attention of the Profiler PTA Balloon Catheter Recall Coordinator at 518-798-1360. The form lists the catalog numbers, lot numbers, and quantity our records indicate your facility has received. For further questions please call 1-800-772-6446.

Device

Device Recall Profiler Balloon Catheter
  • Model / Serial
    Lot 532109 (Use By 2013-12)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including the states of CA, GA, ID, MI, OH and PA.
  • Product Description
    ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 || Cardiovascular catheterization
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Manufacturer Address
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • Manufacturer Parent Company (2017)
    AngioDynamics Inc
  • Source
    USFDA