Recall Z-0440-06 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Scimed
Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. The Sentinol Nitinol Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel tit
| Date | Jan 25, 2006 (initiated May 14, 2004) |
| Status | Terminated |
| Reason | One lot of one catalog number of the Sentinol Nitinol Biliary Stent System may have been packaged in a Sentinol nitinol Vascular outer carton. The product, pouch label and carton label are all correct and the correct DFU is in the package. |
| Root cause | Other |
| Action | A Recall Notice, dated 05/14/04, was sent to appropriate hospital personnel. The Notice described the issue, identified affected product and asked that the use of affected product be discontinued and affected units be segregated. A tracking/verification form is asked to be returned to Boston Scientific and arrangements will be made for retuning the affected product. |
| Quantity | 20 |
| Distribution | Within US to KY, MA, NC, NH, NJ, PA, TX, VA, WA. The following countries were contacted regarding the recall and all reported that no accounts had affected product in their possession: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, India, Indonesia, Vietnam, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032025 | SENTINOL NITINOL BILLARY STENT SYSTEM Boston Scientific Corp, Sep 25, 2003 |