Events

Alerte De Sécurité sur Coronary angioplasty catheter (9000005) ANVISA registration number: 80146501766 Hazard class: IV Model affected: 1012444-06, 1012444-08, 1012444-12, 1012444-15, 1012445-20, 1012445-06, 1012445-12, 1012445-15, 1012445-20, 1012446-06, 1012446-08, 1012446-12, 1012446-15, 1012446-20, 1012447-06, 1012450- 08, 1012447-12, 1012447-20, 1012447-25, 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451- 20, 1012451-25, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20, 1012454-08, 1012454-12, 1012454-15, 1012454-20, 1012455-08, 1012455-12, 1012455-15, 1012455-20. Serial numbers affected: Annex 1

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Abbott Laboratórios do Brasil LTDA; Abbott Vascular.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2234
  • Date
    2017-03-20
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    • Check the list of affected lots and models; • Immediately stop the use of the devices in those batches; • Review stock, complete, sign and return to Abbott VAscular the Efficacy Check letter; • Return all unused units to Abbott VAscular; • Share this notification with all relevant people in your institution. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Batches identified for this field action may have difficulty removing the protective sheath from the balloon, which may result in problems with inflating and deflating the balloon.
  • Action
    Field Action Code March 22, 2017 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will collect.

Device

Coronary angioplasty catheter (9000005) ANVISA registration number: 80146501766 Hazard class: IV ...

Manufacturer

Abbott Laboratórios do Brasil LTDA; Abbott Vascular
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA