Events

Recall of Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK || Catalog Number: CVC961IK

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
    32694
  • Event Risk Class
    Class 2
  • Event Number
    Z-1511-05
  • Event Initiated Date
    2005-07-22
  • Event Date Posted
    2005-09-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40678
  • 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, Suprapubic (And Accessories) - Product Code KOB
  • Reason
    The tearaway introducer sheath may have cracked hubs/handles and/or improper peeling during use.
  • Action
    Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.

Device

Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6...
  • Model / Serial
    Lot Numbers: 970797 975780 976519 984496 991184 1012876 1014484 1015393 1017361 1018981 1019389 1019740 1025515 1028107 1029092
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
  • Product Description
    Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/SL/9.6/IK || Catalog Number: CVC961IK
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

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