Events

Recall of Device Recall Maverick 2 Monorail" PTCA Catheter

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
    48607
  • Event Risk Class
    Class 2
  • Event Number
    Z-2165-2008
  • Event Initiated Date
    2007-05-01
  • Event Date Posted
    2008-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71709
  • 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
    Percutaneous Catheter - Product Code LOX
  • Reason
    The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the port septum wall burts.
  • Action
    Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required" letter dated May 11, 2007. The letter addressed to Risk mangers, described the issue and product. The letter requested the immediate discontinued use of and segregation of recalled product, A Reply Verification Tracking Form was requested to be completed and returned.

Device

Device Recall Maverick 2 Monorail" PTCA Catheter
  • Model / Serial
    Lot 9565194, Exp April 2010.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.
  • Product Description
    Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm || REF 38928-1530 || Lot 9565194 || Use before 2010-04 || Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, One Boston Scientific Place, Natick MA 01760
  • Source
    USFDA