Events

Recall of Device Recall Boston Scientific

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Marlbourgh.

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
    32601
  • Event Risk Class
    Class 2
  • Event Number
    Z-1020-05
  • Event Initiated Date
    2005-07-28
  • Event Date Posted
    2005-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40419
  • 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
    Device, Thermal Ablation, Endometrial - Product Code MNB
  • Reason
    The hysteroscope adapter used with the hta system may disassemble and result in a fluid leak.
  • Action
    Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions

Device

Device Recall Boston Scientific

Manufacturer

Boston Scientific Marlbourgh
  • Manufacturer Address
    Boston Scientific Marlbourgh, 100 Fairbanks Blvd, Marlborough MA 01752-1234
  • Source
    USFDA