Events

Recall of Device Recall Ultraflex tracheobronchial Stent System

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

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
    Recall
  • Event ID
    55784
  • Event Risk Class
    Class 2
  • Event Number
    Z-1825-2010
  • Event Initiated Date
    2010-05-17
  • Event Date Posted
    2010-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91891
  • 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
    Prosthesis, tracheal, expandable - Product Code JCT
  • Reason
    Suture related device failures during deployment and repositioning of the stent.
  • Action
    Boston Scientific issued an "Urgent Medical Device Recall - Immediate Action Required" notification dated May 17, 2010 to U.S. Distributors stating that use and distribution of products should cease immediately and return all affected product to the firm for replacement. Distributors were asked to complete and return reply a verification tracking form. For further information, contact Boston Scientific at 1-866-868-4004.

Device

Device Recall Ultraflex tracheobronchial Stent System
  • Model / Serial
    Lot Numbers: 9719329 9719476 9729181 9747916 9747921 9785574 9785747 11006481 11006663 11042916 11043090 11074295 11074881 11115970 11115971 11160469 11180422 11217496 11217564 11235362 11251397 11251560 11258555 11258557 11275758 11275941 11318345 11318350 11498129 11498131 11565628 11588877 11613354 11613355 11645064 11645070 11729278 11729991 11730401 11744479 11744701 11748621 11748625 11782235 11782320   11804654 11823976 11823977 11828579 11828765 11846774 11846775 11865642 11865645 11901264 11957879 11957942 11958712 11959235 11968138 11968608 11992410 12017068 12107569 12107576 12119779 12120061 12140337 12140501 12159709 12159711 12234169 12234170 12244050 12244051 12250400 12250404 12310678 12320289 12352241 12376738 12393799 12412806 12450877 12496948 12510971 12535301 12598614 12601477 12615078   12651492 12676873 12696897 12755536 12779717 12832673 12843633 12862111 12871361 12901537 12927773 12931867 12982299 13005936 13052037 13065350 13071860 13121813 13131549 13183683 13190261 13263228 13313935 13318995
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - Only US distributed product is affected by recall
  • Product Description
    Ultraflex Tracheobronchial Stent System. Covered - 14/30/15 Catalog Number: M00569040. Single Use, Rx only. Boston Scientific, Natick, MA 01760. || Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA