Events

Recall of Device Recall Arrow VPS Vascular Positioning System Console and Stylet Extension Cable

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

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
    70927
  • Event Risk Class
    Class 2
  • Event Number
    Z-1408-2015
  • Event Initiated Date
    2015-03-30
  • Event Date Posted
    2015-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135563
  • 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, ultrasound, intravascular - Product Code OBJ
  • Reason
    A limited number of vps g4 consoles are being recalled due to noncompliance with international electrotechnical commission standard 60101-1-1.
  • Action
    Teleflex sent an Urgent Medical Device Recall Notification letters dated on March 30, 2015 to all affected customers. The letters identified the affected product, problem and actions to be taken. The risk to users is identified and users are asked to discontinue use and quarantine affected serial numbers. Teleflex sales reps will help with return of product. The Acknowledgeable form should be completed and returned as per instructions. Questions should be directed to 1.877.236.6869.

Device

Device Recall Arrow VPS Vascular Positioning System Console and Stylet Extension Cable
  • Model / Serial
    Product code VPS-G4C; Serial numbers: GB40129, GB40130, GB40131, GB40133, GB40136, GB40146, GB40148, GB40151, GB40152, GB40154, GB40155, GB401456, GB40157, GB40158, GB40168, GB40175, GB40186
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AZ, DC, PA, IN, PA. GA, NY, KS, CA, VA, NC.
  • Product Description
    VasoNova Vascular Positioning System (VPS ) G4 Console || Catalog number VPS-G4C || Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
  • Manufacturer
    VasoNova, Inc.

Manufacturer

VasoNova, Inc.
  • Manufacturer Address
    VasoNova, Inc., 155 Jefferson Dr, Menlo Park CA 94025-1114
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA