Events

Safety Alert for Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class: II Affected Model: 1009-00 Serial Numbers Affected: ELVH1102V

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Tecmedic Comércio de Produtos Médicos Ltda; 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
    2187
  • Date
    2017-02-07
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    For products that were already used in patient, the manufacturer did not request any further action.
  • Reason
    Tecmedic comércio de produtos médicos ltda., on 05/02/2017 received notification of collection of lot elvh1102v of reference 1009-00 of the product valvulotomo hydro longo lemaitre, registered with anvisa under nº 80202919003. this collection was initiated due to to reported problems of failure of the rims to close when the device was triggered. in some cases, this problem was discovered in use and led to damage in the vessel. if the blades are locked in the open position, the device must be removed in the open position. removal of the unassembled device may cause damage to the vein or during use or when the blades pass through the vessel. the manufacturer lemaitre requested the immediate recall of the valvulotomo hydro long lemaitre, model 1009-00, lot elvh1102v and the proper segregation of the parts. after this recall, the manufacturer requested that all units be shipped to lemaitre. for the valvuloto hydro long lemaitre units of the elvh1102v batch used, the manufacturer did not request any further action. tecmedic imported 23 units from the affected lot.
  • Action
    Field Action Code CWB 02/2017 triggered under the responsibility of the company Tecmedic Comércio de Produtos Médicos Ltda. Company will collect.

Device

Trade name: Valvulotome Hydro Longo Lemaitre ANVISA Registration Number: 80202919003 Hazard Class...

Manufacturer

Tecmedic Comércio de Produtos Médicos Ltda; Lemaitre Vascular Inc
  • Source
    ANVSANVISA