Z-0015-2011

Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF...

Name: Z-0015-2011 Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF...
Creator: Navilyst Medical, Inc
Published: 2010-05-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2010-05-24 / Terminated / root cause: manufacturing process

FDA source

Navilyst Medical, Inc began a recall of Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY... on 2010-05-24. The reason FDA records is "One box containing five catheters did not complete the sterilization process prior to distribution". 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-0015-2011
Status: Terminated
Initiated: 2010-05-24
Posted: 2010-10-07
Terminated: 2010-10-07
Recalling firm: Boston Scientific Corporation
Product: Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: One box containing five catheters did not complete the sterilization process prior to distribution.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On/about 5/24/10, NMI telephoned the consignee. The recall notification package was sent by NMI to the sole consignee on 6/11/10, followed by a telephone call by NMI Quality staff. On 6/15/10, the recall notification package was sent via FedEx to the sole consignee. Subsequently the consignee was provided a return goods authorization (RGA) number for return to NMI. The letter described the product, problem and action to be taken by the consignee/customer. The consignee/customer was instructed to immediately discontinue use of and segregate recalled product; remove the affected lot from their inventory; complete and return the Reply Verification Tracking Form via fax to the QA Manager; Navilyst Medical, Inc., at 1-518-742-4414; to please call the Navilyst Medical Customer Service at 1-800-833-9973 between 8:30 a.m. and 7:00 p.m. (Eastern Standard Time) to obtain a Return Authorization (RGA) Number, and package/ship the recalled product to Navilyst Medical, Inc, Distribution Center, Attn: QA Returns, 10 Glens Falls Technical Park, Glens Falls, NY 12801. If you have any questions, call Navilyst Medical Customer Service at 1-800-833-9973. Subsequent to the initial notification letter, NMI identified that a typo was made to the lot number on the letter. NMI telephoned the consignee and sent a revised letter via fax on 6/25/10 indicating the correct lot number.
Quantity in commerce: 1 box unit (contains 5 catheters)
Distribution: Nationwide distribution: Ohio only
Product codes and lots: Lot 1PD0050401

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)