Events

Recall of Device Recall Boston Scientific NexStent Monorail

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
    48697
  • Event Risk Class
    Class 1
  • Event Number
    Z-2141-2008
  • Event Initiated Date
    2008-06-06
  • Event Date Posted
    2008-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71925
  • 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
    carotid stent and delivery system - Product Code NIM
  • Reason
    Tip detachment: boston scientific has received complaints involving a detachment of the tip from the nexstent carotid stent delivery system. potential health hazards resulting from this type of failure include increased procedure time, vessel wall injury, stroke and/or emergency surgery to remove the detached tip. since the potential for the tip to detach occurs during delivery of the sten.
  • Action
    Boston Scientific sent an urgent Voluntary Medical Device Recall letter, dated 06/06/08, to affected customers. The letter described the issue, identified affected product, requested to cease using or distributing the product and provided direction on how to return the recalled devices to Boston Scientific, Quincy, MA. A Reply Verification Tracking Form was asked to be returned to Boston Scientific. Since the issue is with the delivery system, patients already implanted with the stent are not affected.

Device

Device Recall Boston Scientific NexStent Monorail
  • Model / Serial
    US Lot/Batch #: C71403, C71404, C71405, C71406, C71501, C71502, C71601, C71602, C72302, C72303, C72401, C72402, C72403, C72404, C72701, C72801, C72802, C72803, C72901, C72902, C72903, C72904, C73002, C73003, C73103, C73104, C73105, C73201, C73202, C73203, C73204, C73205, C73301, C73302, C73401, C73402, C73601, C73602, C73801, C74301, C74302, C74401, C74502, C74601, C74701, C80201, C80202, C80203, C80301, C80401, C80402, C80403, C80501, C80801, C80802, C81001, C81002, C81102, C81201, C81202, and C81203.   OUS Lot/Batch #: C72501, C72502, C72601, C72602, C72905, C73001, C73004, C73101, C73102, C73901, C73902, C73903, C74001, C74002, C74003, and C74101
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Kuwait, Luxembourg, Netherlands, Norway, Panama, Poland, Portugal, Romania, Spain, Switzerland, and Ukraine.
  • Product Description
    Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System. Material Number (UPN) M001553030, Catalog Number 55-303. [OUS Material Number (UPN) M001553000, Catalog Number 55-300]
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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