Events

Recall of Boston Scientiific PCNL

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
    37886
  • Event Risk Class
    Class 2
  • Event Number
    Z-0889-2007
  • Event Initiated Date
    2007-04-11
  • Event Date Posted
    2007-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52058
  • 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 Tract Kit - Product Code LJE
  • Reason
    Mislabeled: outer box unit has correct part number but product is incorrectly identiified as a percutaneous tract kit with nephromax balloon. the box actually contains a percutaneous tract kit with amplatz dilator and sheath kit.
  • Action
    Boston Scientific notified customers on 4/11/07 by letter via Federal Express mail. Users are requested to return product in inventory.

Device

Boston Scientiific PCNL
  • Model / Serial
    Batch/Lot Numbers: 8529320, 8568190, 9371965
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution; USA including states of OH, MS, NM, MD, and TX and Foreign country of Trinidad
  • Product Description
    Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; || Part Number: M0064501110
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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