Events

Recall of Device Recall Silicone PICC catheter with PASV Valve.

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
    31811
  • Event Risk Class
    Class 2
  • Event Number
    Z-1052-05
  • Event Initiated Date
    2004-03-05
  • Event Date Posted
    2005-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38607
  • 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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Reason
    Lumens may have incorrect lumen size marked on them.
  • Action
    Letters dated March 5, 2004 with instructions to return product to Boston Scientific.

Device

Device Recall Silicone PICC catheter with PASV Valve.
  • Model / Serial
    898659, 899145
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,
  • Product Description
    PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA