Alerta De Seguridad para Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter medical device manufacturer, medtronic, has issued a medical device safety alert concerning its amphirion deep percutaneous transluminal angioplasty (pta) balloon dilation catheter. the affected products are identified as follow: model number:amd015020002, amd020120152, amd025150152, amd030150152, amd040120002, amd335210002, amd015020151, amd020150002, amd030040002, amd035040152, amd040120152, amd335210152, amd015020152, amd020150152, amd030040152, amd035120002, amd040150002, amd354210002, amd020040002, amd025040152, amd030080002, amd035150002, amd040150152, amd354210152, amd020040152, amd025080152, amd030080152, amd035150152, amd225210002, amd020080002, amd025120002, amd030120002, amd040040152, amd225210152, amd020080152, amd025120152, amd030120152, amd040080002, amd253210002, amd020120002, amd025150002, amd030150002, amd040080152, amd253210152 medtronic is conducting a voluntary urgent medical device recall of the affected products due to a potential breach of pouch seal for the product manufactured in select lots. according to the manufacturer, they did not receive any customer complaint or report of adverse patient events regarding improperly sealed pouches. the potential for the breach in the pouch enclosing the sterilized product was discovered during internal packaging testing, which involved exposure to extreme use conditions. the manufacturer requests the customers to identify and quarantine all unused, affected product in their inventory, and return them to the manufacturer. patients who have received treatment with the devices affected by the recall should continue to be monitored in accordance with the physician’s standard practice. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 26 october 2015.


  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source