Events

Safety Alert for Expandable Valvulotome

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Lemaitre Vascular Inc..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1609-406
  • Event Number
    2009DM-0005091
  • Date
    2016-09-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=119
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected the possibility that the device can be damaged when the rings are closed, leading to potentially serious adverse events on the patients.

Device

Expandable Valvulotome
  • Model / Serial
    1009-00 and 1009-00J, lots ELVH1082V, ELVH1083V, ELVH1085V, ELVH1086V, ELVH1078V, ELVH1079VA, || ELVH1071VA, ELVH1080V, ELVH1094VA, ELVH1097V, || ELVH1100V, and ELVH1108VA.
  • Product Description
    Excision of saphenous vein valves in in situ derivation interventions.
  • Manufacturer
    Lemaitre Vascular Inc.

Manufacturer

Lemaitre Vascular Inc.