Recall of Device Recall Sentinol Nitinol Biliary Stent System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Scimed.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
  • 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.
  • 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.


  • Model / Serial
    UPN # H7493894886070, lot # 6412353
  • Product Classification
  • Device Class
  • Implanted device?
  • 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, Israel, Korea, Malaysia, Mexico, Philippines, Singapore, South Africa, Taiwan, Thailand, Turkey, Uruguay, Andean & Caaribbean Countries, Cyprus, Balkins, Puerto Rico, Bahrain, Egypt, Jordan, Kuwait, Lebanon, Morocco, Oman, Pakistan, Qatar, Saudi Arabia, Syria, Tunisia, Yemen, United Arib Emirates
  • Product Description
    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 titanium alloy(nitinol). The stent is constrained within a 6F delivery system. The delivery system is of coaxial design with an exterior shaft to protect and constrain the stent prior to deployment. An inner shaft, with two radiopaque markers, aids in the placement of the stent. The delivery system is compatible with 0.035 in. (0.89mm) guidewires. When ready to be implanted, the stent is deployed by retracting the exterior shaft of the delivery system. As the stent is exposed to body temperature it expands to appose the duct wall.
  • Manufacturer


  • Manufacturer Address
    Boston Scientific Scimed, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source