Events

Recall of Liberte Monorail and OvertheWire Coronary Stent Systems

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
    53435
  • Event Risk Class
    Class 2
  • Event Number
    Z-0068-2010
  • Event Initiated Date
    2009-09-11
  • Event Date Posted
    2009-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85496
  • 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
    Stent, coronary - Product Code MAF
  • Reason
    Boston scientific initiated a field correction for the liberte¿ bare-metal coronary stent products. they have received reports from cardiac cath labs that taxus liberte paclitaxel-eluting (taxus¿ libert¿¿ drug-eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a liberte¿ bare-metal stent, and libert¿¿ bare-metal stents have been ina.
  • Action
    Boston Scientific issued an "Urgent Medical Device Field Correction" letter dated September 18, 2009. The letter was addressed to Risk Manger/Field Action Contact. The letter described the product, problem and actions which included renaming the Liberte¿¿ Bare-Metal stent as VeriFlex" Bare-Metal stent. Enclosed with the letter included the Direction for Field Correction and a Reply Verification Tracking Form. For further information, contact you local Boston Scientific Sales Representative or call 1-800-811-3211.

Device

Liberte Monorail and OvertheWire Coronary Stent Systems
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution -- United States including Puerto Rico.
  • Product Description
    Boston Scientific Liberte¿¿ Monorail¿ and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". || The Liberte¿¿ Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte¿ Monorail¿ (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte¿ system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation.
  • 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