Events

Recall of Device Recall ClariVein IC infusion catheter

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

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
    79324
  • Event Risk Class
    Class 2
  • Event Number
    Z-1146-2018
  • Event Initiated Date
    2017-11-09
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161969
  • 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, continuous flush - Product Code KRA
  • Reason
    Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.
  • Action
    Vascular Insights sent an Urgent Voluntary Medical Device Recall letter to their customers. The letter identified the affected product, problem and the actions to be taken. Customers were instructed to 1. Do not use or distribute any recalled product. 2. Immediately remove all recalled product from your inventory. 3. Segregate recalled product in a secure location and follow the instruction herein to return the recalled product and receive replacement product. 4. Immediately forward a copy of this recall notification to any/all sites to which you may have distributed the affected product and provide directions to follow the instructions contained herein. Customers were asked to complete and return the enclosed Reply Verification Tracking Form.

Device

Device Recall ClariVein IC infusion catheter
  • Model / Serial
    Lot number: BM651403017I
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S Nationwide in the states: AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MO, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA
  • Product Description
    ClariVein IC infusion catheter, Model Number: 65-018-E4S || Product Usage: || The ClariVein IC infusion catheter is indicated for infusion of physician-specified agents into the peripheral vasculature.
  • Manufacturer
    Vascular Insights, LLC

Manufacturer

Vascular Insights, LLC
  • Manufacturer Address
    Vascular Insights, LLC, 1 Pine Hill Dr Ste 100, Quincy MA 02169-7485
  • Manufacturer Parent Company (2017)
    Vascular Insights, LLC
  • Source
    USFDA