Events

Safety Alert for Trade name: Valvulotomo Hydro Lemaitre Longo. Technical Name: Valvulotomo. ANVISA registration number: 80202919003. Class of risk: II. Affected Model:. Serial numbers affected: ELVH1082V

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
    1985
  • Date
    2016-09-14
  • 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
    Recommendations to users and patients: The manufacturer requested the collection of the lot and the proper segregation of the units collected. After the recall, the manufacturer requests that all units be sent to Lemaitre. Regarding the products that were already used, the manufacturer did not request any further action.
  • Reason
    The company clarifies that on 05/08/2016, an official recall statement was received from the manufacturer lemaitre vascular inc, of the product valvulootro hydro longo lemaitre, model 1009-00, lot elvh1082v, of which 5 units were sent to brazil and received on 06/23/2016, according to nf 60436. such collection is due to reported failure to close hoops at the moment of the drive. in some cases, this problem was discovered during use. although there are no reports of adverse events, there is a possibility that a malfunction of the device could damage the vessel at the time of withdrawal. the manufacturer requested the collection of the lot and the proper segregation of the collected units. after the recall, the manufacturer requests that all units be sent to lemaitre. regarding the products that were already used, the manufacturer did not request any further action.
  • Action
    Field Action No. CWB21 triggered under the responsibility of Tecmedic Comércio de Produtos Médicos Ltda. Risk classification: III (Risk of serious adverse event occurrence) Classification of the field action: Recollection; Return to the manufacturer.

Device

Trade name: Valvulotomo Hydro Lemaitre Longo. Technical Name: Valvulotomo. ANVISA registration nu...

Manufacturer

TECMEDIC COMÉRCIO DE PRODUTOS MÉDICOS LTDA.; Lemaitre Vascular Inc.
  • Source
    ANVSANVISA