Events

Recall of Device Recall CVI (Cardiovascular Innovations)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lemaitre Vascular, 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
    38894
  • Event Risk Class
    Class 2
  • Event Number
    Z-0008-2008
  • Event Initiated Date
    2007-07-18
  • Event Date Posted
    2007-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=54520
  • 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
    contrast media injector - Product Code DXT
  • Reason
    Sterility of device may be compromised due to breach in sterile barrier.
  • Action
    The firm issued a "Adivsory Notice" to accounts 7/18/07, advising them to examine inventory and remove product with defective packaging. The firm issued an updated notification dated 9/24/07 advising users to return recalled lots instead of conducting an examination of the product at the user site.

Device

Device Recall CVI (Cardiovascular Innovations)
  • Model / Serial
    Lot Numbers: XX-02-X; XXX-03-X; XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07; 046-07, where X is any number.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, Netherlands, and Germany.
  • Product Description
    CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

Lemaitre Vascular, Inc.
  • Manufacturer Address
    Lemaitre Vascular, Inc., 63 Second Avenue, Burlington MA 01803-4413
  • Source
    USFDA