Recall of Device Recall DuraMax Chronic Hemodialysis 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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, hemodialysis, implanted - Product Code MSD
  • Reason
    Angiodynamics received customer complaints for breakage of the tunneler sleeve during product use.
  • Action
    The firm, AngioDynamics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to ANGIODYNAMICS (replacement product will be shipped upon receipt and confirmation of the returned product). If the customers are in immediate need for replacement product, they should fax the completed Recall Reply Form, along with a copy of the product label, to Customer Service at (518) 798-1360 or call us at (800) 772-6446, x1358 or x1363. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call ANGIODYNAMICS customer service at 1-800-772-6446 or email to:


  • Model / Serial
    Lots 527842, C28715
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide distribution.
  • Product Description
    DURAMAX 15.5 F x 32 cm Chronic Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32 cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804 USA || The AngioDynamics DuraMax¿ Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.
  • Manufacturer


  • Manufacturer Address
    Angiodynamics, Inc., 603 Queensbury Avenue, Queensbury NY 12804
  • Manufacturer Parent Company (2017)
  • Source