Recall of Device Recall Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Navilyst Medical, 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, biliary, diagnostic - Product Code FGE
  • Reason
    Navilyst medical, inc. determined that the exodus standard loop biliary drainage catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
  • Action
    The firm, Navilyst Medical, sent an "Urgent Medical Device Recall -Immediate Action Required" letter dated February 4, 2011, via Federal Express to the domestic consignees/customers and one foreign consignee/customer. Consignees/customers were instructed to: (1.) Immediately discontinue use and remove the recalled product from inventory; (2.) Segregate this product in a secure location for return to Navilyst Medical, Inc.; (3.) Immediately forward a copy of the recall notification to ALL sites to which they have distributed affected device (4.) promptly complete and return the Reply Verification Tracking Form (even if you do not have any product to return) via fax to: QA Manager, Navilyst Medical, Inc., 1-800-782-1357; (5.) call Customer Service at 1-800-833-9973 between to 7:00pm EST to obtain RMA number; (6.) package and return the recalled product; and (7.) Physicians were instructed to continue to monitor their patients and evaluate per institutional protocol for biliary catheters. If you have any questions about this recall action, your local Sales Representative is available to assist you or contact QA Manager, Navilyst Medical, Inc., directly at 518-742-4571.


  • Model / Serial
    Lots 1ML0052506, 1ML0062201, 1ML0080901
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AK, AZ, CA, CO, FL, IL, KS, MI, MO, NC, NJ, NY, OH, OK, PA, PR and country of: South Africa.
  • Product Description
    Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Centennial Blvd. Jeffersonville, IN 47130 -- Manufactured for: Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752 || --- The Exodus Drainage Catheter consists of a radiopaque || polyurethane catheter. The distal end of the catheter is configured as a J-Tip or a locking pigtail and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance from the distal tip. The Exodus Biliary Drainage Catheter includes a radiopaque (RO) marker band located approximate 5 mm from the most proximal drainage hole to assist with catheter placement. || Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
  • Manufacturer


  • Manufacturer Address
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
  • Source