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Vista de la lista Vista de las tarjetas
  • Dispositivo 42
  • Fabricante 18
  • Evento 124969
  • Implante 1
Retiro De Equipo (Recall) de Pulsar-18
  • Tipo de evento
    Recall
  • ID del evento
    2018-0685
  • Fecha
    2018-03-15
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • URL de la fuente del evento
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de Yankauer Suction Tubing, Penrose Tubing, Trocar Catheter, Thoracic C...
  • Tipo de evento
    Recall
  • ID del evento
    2018-0726
  • Fecha
    2018-03-19
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de Flex Arm
  • Tipo de evento
    Recall
  • ID del evento
    2018-0758
  • Fecha
    2018-03-22
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de Comprehensive Distal Humeral Body
  • Tipo de evento
    Recall
  • ID del evento
    2018-0760
  • Fecha
    2018-03-22
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de Monoclonal Mouse, Anti-Pneumocystis J. & Anti Huma
  • Tipo de evento
    Recall
  • ID del evento
    2018-0784
  • Fecha
    2018-03-26
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de StoneBreaker® Pneumatic Lithotripter
  • Tipo de evento
    Recall
  • ID del evento
    2018-0785
  • Fecha
    2018-03-26
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de 5mm ENDOPATH® XCEL™ Bladeless Trocars with Optiview Technology, 5mm ...
  • Tipo de evento
    Recall
  • ID del evento
    2018-0787
  • Fecha
    2018-03-26
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de LigaSure™ Exact Dissector, Nano-coated 20.6mm-21cm
  • Tipo de evento
    Recall
  • ID del evento
    2018-0791
  • Fecha
    2018-03-26
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - packing - sterility.
Retiro De Equipo (Recall) de Altius Central Venous Catheter Kit
  • Tipo de evento
    Recall
  • ID del evento
    2018-0813
  • Fecha
    2018-03-28
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - manufacturing.
Retiro De Equipo (Recall) de Blue Suture Grasper,Blue Suture Grasper, RANFAC Bone MARROW BIOPSY N...
  • Tipo de evento
    Recall
  • ID del evento
    2018-0837
  • Fecha
    2018-04-03
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Other.
Retiro De Equipo (Recall) de B5 2Shape TS1 n25 4% L31 Classics sterile
  • Tipo de evento
    Recall
  • ID del evento
    2018-0839
  • Fecha
    2018-04-03
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de BD Vacutainer® Plus Citrate tube
  • Tipo de evento
    Recall
  • ID del evento
    2018-0852
  • Fecha
    2018-04-04
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
Retiro De Equipo (Recall) de 3 ways stopcock
  • Tipo de evento
    Recall
  • ID del evento
    2018-0965
  • Fecha
    2018-04-13
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - manufacturing.
Retiro De Equipo (Recall) de EEA™ Hemorrhoid and Prolapse Stapler Set with DST Series™ Technology
  • Tipo de evento
    Recall
  • ID del evento
    2018-0969
  • Fecha
    2018-04-13
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - manufacturing.
Retiro De Equipo (Recall) de Aequalis Humerail Nail Drill Bit Sterile
  • Tipo de evento
    Recall
  • ID del evento
    2018-0988
  • Fecha
    2018-04-18
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - packing - sterility.
Retiro De Equipo (Recall) de Tubing Sets for Hemodialysis / NovaLine®
  • Tipo de evento
    Recall
  • ID del evento
    2018-1058
  • Fecha
    2018-04-25
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Unclear about the previous relationship.
Retiro De Equipo (Recall) de Soft-Trans Embryo Transfer Catheter
  • Tipo de evento
    Recall
  • ID del evento
    2018-1072
  • Fecha
    2018-04-26
  • País del evento
    Finland
  • Fuente del evento
    VNSAWH
  • Notas / Alertas
    Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
  • Notas adicionales en la data
    Source: FSCA
  • Causa
    Device failure / feature before use - manufacturing.
Notificaciones De Seguridad De Campo acerca de AVEA Ventilator
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20131006_01
  • Fecha de publicación del evento
    2013-10-07
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20131006_01
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Ciaglia Blue Dolphin Balloon Percutaneous Tracheos...
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20100505_10
  • Fecha de publicación del evento
    2010-05-10
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20100505_10
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Shiley Reusable Cannula cuffed tracheostomy tubes
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20120725_20
  • Fecha de publicación del evento
    2012-07-30
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20120725_20
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Shiley Neonatal and Pediatric Tracheostomy tube
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20150519_07
  • Fecha de publicación del evento
    2015-05-26
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20150519_07
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Aisys carestation
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20131023_04
  • Fecha de publicación del evento
    2013-10-28
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20131023_04
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Avance CS2
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20131023_04
  • Fecha de publicación del evento
    2013-10-28
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20131023_04
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Fabius Anaestesia Units
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20130814_01
  • Fecha de publicación del evento
    2013-08-19
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20130814_01
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Evita lnfinity V5OO, Babylog VN5OO, Evita V300
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20140225_07
  • Fecha de publicación del evento
    2014-03-04
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20140225_07
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Notas adicionales en la data
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