{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "106450", "product_res_number": "Z-0648-2012", "event_date_initiated": "2011-02-04", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-01-10", "res_event_number": "60775", "product_code": "FGE", "k_numbers": [ "K093392" ], "product_description": "Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog No. 10013, UPN/Product No. H965100131, 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 USA --- 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.\n\nBiliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.", "code_info": "Lots 1ML0060705, 1ML0070901, 1PD0040501", "firm_fei_number": "3017892510", "recalling_firm": "Navilyst Medical, Inc", "address_1": "10 Glens Falls Technical Park", "city": "Glens Falls", "state": "NY", "postal_code": "12801", "additional_info_contact": "Michael Duerr\n518-742-4571", "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.", "root_cause_description": "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. \n\nIf 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_pattern": "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.", "openfda": { "k_number": [ "K851956", "K112543", "K980191", "K913932", "K990592", "K993588", "K821817", "K003450", "K912122", "K033497", "K024303", "K844384", "K020682", "K980372", "K014007", "K900904", "K920236", "K910493", "K072301", "K002650", "K000564", "K210419", "K963397", "K032530", "K003186", "K823428", "K974815", "K910671", "K000550", "K041796", "K033134", "K924608", "K083627", "K992318", "K990854", "K896504", "K042518", "K021630", "K152524", "K894871", "K033834", "K032457", "K965147", 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