Events

Recall of PTFE (Polytetrafluoroethylene) felt.

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

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
    31998
  • Event Risk Class
    Class 2
  • Event Number
    Z-0931-05
  • Event Initiated Date
    2005-04-19
  • Event Date Posted
    2005-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38889
  • 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
    Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene - Product Code DXZ
  • Reason
    Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
  • Action
    Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.

Device

PTFE (Polytetrafluoroethylene) felt.
  • Model / Serial
    Lot Numbers:  7337514; 7337515; 7337516; 7337717; 7350604; 7356745; 7356747; 7359759; 7359760; 7360535; 7360536; 7384480; 7384483; 7384484; 7384485; 7384486; 7384487; 7412113.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The product was distributed to hospitals nationwide.
  • Product Description
    PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, || M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.
  • Manufacturer
    Boston Scientific Scimed

Manufacturer

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