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-1827-2010
  • 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=91893
  • 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: 9634841 9634845 9721675 9727354 9727372 9765848 9766323 9817320 9817497 9823497 9824440 11005050 11005053 11041572 11041573 11060439 11061476 11063331 11063374 11096068 11096073 11119006 11119173 11152523 11153335 11169338 11169594 11197217 11249077 11250366 11255391 11255392 11260093 11260352 11267520 11268170 11273309 11273315 11338177 11338360 11357474 11357581 11404600 11404603 11429217   11429701 11465855 11465859 11478134 11478135 11506003 11506008 11525146 11525151 11560635 11560741 11563824 11565626 11581527 11581529 11592362 11592363 11601963 11601964 11647778 11647839 11676517 11676740 11680039 11680220 11700034 11700221 11703828 11703830 11750111 11750113 11771497 11771664 11774304 11774308 11774845 11787063 11787064 11814052 11814054 11847077 11847078 11847079 11847100 11847101   11847102 11875440 11875445 11877337 11877339 11888467 11888470 11924826 11924839 11925156 11925324 11934143 11934144 12001530 12001748 12002494 12002820 12008477 12013635 12013636 12014267 12014268 12033293 12033298 12120841 12120848 12125328 12125523 12148793 12149185 12199930 12200253 12219246 12219250 12225782 12225783 12238688 12238689 12298022 12298031 12303604 12316035 12333642 12374153 12384435   12397962 12403279 12421962 12445505 12479777 12514709 12529441 12565953 12571272 12605210 12624519 12632783 12639187 12655072 12675646 12685515 12727552 12739070 12742771 12776530 12829072 12833391 12836271 12860941 12880204 12895590 12916220 12935597 12976131 12989433 12992137 12992930 13022704 13047831 13051711 13058915 13072983 13141887 13148451 13149042 13149052 13180609 13182177 13183332 13185668   13248151 13253753
  • 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 - 12/30/15 Catalog Number: M00569060. 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