Z-0648-2012

Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog...

Name: Z-0648-2012 Exodus(TM) 10 F (3.4 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog...
Creator: Navilyst Medical, Inc
Published: 2011-02-04
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-02-04 / Terminated / root cause: manufacturing process

FDA source

Navilyst Medical, Inc began a recall of 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... on 2011-02-04. The reason FDA records is "Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0648-2012
Status: Terminated
Initiated: 2011-02-04
Posted: 2012-01-11
Terminated: 2012-01-10
Recalling firm: Boston Scientific Corporation
Product: 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. Biliary Drainage Catheters are intended for percutaneous drainage of the biliary tree.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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 tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lots 1ML0060705, 1ML0070901, 1PD0040501

Product code FGE

K093392Class IIMultipurpose, Nephrostomy and Biliary Drainage CathetersNavilyst Medical, Inc. / cleared 2009-12-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)