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U.S. Department of Health and Human Services

Class 2 Device Recall Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating

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  Class 2 Device Recall Exodus(TM) Standard Loop Biliary Drainage Catheter with Hydrophilic Coating see related information
Date Initiated by Firm February 04, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on January 10, 2012
Recall Number Z-0647-2012
Recall Event ID 60775
510(K)Number K093392  
Product Classification Catheter, biliary, diagnostic - Product Code FGE
Product 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.
Code Information Lots 1ML0052506, 1ML0062201, 1ML0080901
Recalling Firm/
Navilyst Medical, Inc
10 Glens Falls Technical Park
Glens Falls NY 12801
For Additional Information Contact Michael Duerr
Manufacturer Reason
for Recall
Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.
FDA Determined
Cause 2
Nonconforming Material/Component
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 8:30.am 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.
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = NAVILYST MEDICAL, INC.