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  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Alerta De Seguridad para heat exchanger
  • Tipo de evento
    Safety alert
  • ID del evento
    I1408-333
  • Número del evento
    2009EBC-0003841
  • Fecha
    2014-08-08
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=198
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that contamination and multiplication by mycobacterium chimera can potentially occur inside the equipment if the disinfection instructions do not match, in addition to chimaeramycobacterium contamination, these micro-bacteria may be present in tap water, this practice may lead to their occurrence potentially serious adverse events on the patient.
Alerta De Seguridad para heat exchanger
  • Tipo de evento
    Safety alert
  • ID del evento
    I1612-560
  • Número del evento
    2009EBC-0003841
  • Fecha
    2016-12-07
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that in studies conducted it has detected the possibility that the referenced equipment presents a risk of mycobacterium chimaera infection when they are used in open surgery procedures, because of the possibility that the water used in the equipment for temperature changes will become contaminated, because it does not follow the cleaning and disinfection instructions recommended by the manufacturer, the contaminated water could be aerosolized in the equipment and come into contact with the exposed patient, leading to the occurrence of possible adverse events on the patients.
Alerta De Seguridad para Heart-lung machine systems
  • Tipo de evento
    Safety alert
  • ID del evento
    I1612-569
  • Número del evento
    2009EBC-0004492
  • Fecha
    2016-12-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=110
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer warns that it has detected the possibility that the referenced devices have a sudden deceleration or blocking of blood flow from the centrifugal pump head when used with the terumo sarns adapter, leading to possible serious adverse events on the patient.
Alerta De Seguridad para Heart-lung machine systems
  • Tipo de evento
    Safety alert
  • ID del evento
    I1711-533
  • Número del evento
    2009EBC-0004492
  • Fecha
    2017-11-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=64
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
Alerta De Seguridad para Adult and Pediatric Oxygenators
  • Tipo de evento
    Safety alert
  • ID del evento
    I1607-307
  • Número del evento
    2015DM-0003607-R1
  • Fecha
    2016-07-28
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer states that it has detected the possibility of cross-contamination when using 3t heat generators, originating in the tubes that connect the water circuit, leading to the occurrence of possible adverse events on the patients.
Alerta De Seguridad para Cardiac Valve Auto - Expandable Without Suture PERCEVAL S -
  • Tipo de evento
    Safety alert
  • ID del evento
    I1703-109
  • Número del evento
    2014DM-0012018
  • Fecha
    2017-03-23
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=96
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that as a result of some cases of central or perioperative leakage, it is providing clarifications regarding the implantation instructions that will be integrated into the instructions for use (ifu) and will provide a guide that provides a detailed and illustrated description of the steps of preparing the valve and of implementation as support material, the foregoing as a preventive action to reduce the probability of presenting serious events about patients.
Alerta De Seguridad para Cannulas
  • Tipo de evento
    Safety alert
  • ID del evento
    R1706-251
  • Número del evento
    2011DM-0007684
  • Fecha
    2017-06-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=81
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that due to an improvement in its monitoring process, it has found that some of the referenced devices may present an excess of plastic at the end of the cannula, if said excess is released during the use of the device it could result in the bloodstream, leading to potentially present adverse events on patients.
Alerta De Seguridad para Cardiac Valve Auto - Expandable Without Suture Perceval S
  • Tipo de evento
    Safety alert
  • Número del evento
    2014DM-0012018
  • Fecha
    2018-09-10
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=39
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
Alerta De Seguridad para Heat exchanger
  • Tipo de evento
    Safety alert
  • Fecha
    2019-05-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=10
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
Alerta De Seguridad para Heat exchanger
  • Tipo de evento
    Safety alert
  • Fecha
    2019-01-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=23
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
Alerta De Seguridad para non-adherent dressing to cover wounds Metalline
  • Tipo de evento
    Safety alert
  • ID del evento
    R1607-306
  • Número del evento
    2009DM-0003399
  • Fecha
    2016-07-27
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=130
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected the possible presence of needles or segments of needles on or inside the non-woven layer of some finished products, considered as a contaminated product, leading to possible adverse events on the patients or users.
Alerta De Seguridad para respiratory assistance systems (CPAP / BIPAP)
  • Tipo de evento
    Safety alert
  • ID del evento
    I1404-141
  • Número del evento
    2012DM-0008590
  • Fecha
    2014-04-10
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=205
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected in isolated cases, that a diode in the power board can be subjected to an overvoltage, causing the power supply to be shut off and therefore the device to stop, leading to potentially adverse events occurring on the patient.
Alerta De Seguridad para transport and emergency fans
  • Tipo de evento
    Safety alert
  • Fecha
    2019-05-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=9
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
Alerta De Seguridad para Knee System COLUMBUS
  • Tipo de evento
    Safety alert
  • ID del evento
    R1710-519
  • Número del evento
    2007DM-0000781
  • Fecha
    2017-10-31
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has confirmed that as part of the continuous improvement of the product, the dimensions of the previous articles have been modified, the modified version of the devices is not compatible with the components of the previous version of the columbus, the joint application of both versions may result a premature loosening of the prosthesis, leading to potential adverse events being presented to patients.
Alerta De Seguridad para Clips for Ligation and Marking AESCULAP
  • Tipo de evento
    Safety alert
  • ID del evento
    I1801-65
  • Número del evento
    2009DM-0004475
  • Fecha
    2018-01-29
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=59
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
Alerta De Seguridad para dialog + hemodialysis equipment
  • Tipo de evento
    Safety alert
  • ID del evento
    A1606-243
  • Número del evento
    2008EBC-0001989
  • Fecha
    2016-06-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=136
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has detected that a "too high temperature (sup)" alarm may occur due to a software failure, which is only present during the hemodialysis treatment, which may lead to the occurrence of potentially serious adverse events. the user.
Alerta De Seguridad para DIALOG Hemodialysis Equipment
  • Tipo de evento
    Safety alert
  • ID del evento
    R1605-203
  • Número del evento
    2008EBC-0001989
  • Fecha
    2014-06-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=202
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has detected the presence of cracks in the conductivity sensors, which could allow elaire to enter the solution (dialysis fluid or dialysate) used to help filter waste and other fluids into the blood, the air into the liquid dialysis can lead to inappropriate blood filtration, leading to adverse events on patients.
Alerta De Seguridad para DIALOG Hemodialysis Equipment
  • Tipo de evento
    Safety alert
  • ID del evento
    R1605-203
  • Número del evento
    2008EBC-0001989
  • Fecha
    2016-05-11
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=141
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has detected the presence of cracks in the conductivity sensors, which could allow elaire to enter the solution (dialysis fluid or dialysate) used to help filter waste and other fluids into the blood, the air into the liquid dialysis can lead to inappropriate blood filtration, leading to adverse events on patients.
Alerta De Seguridad para dialog + hemodialysis equipment
  • Tipo de evento
    Safety alert
  • ID del evento
    I1611-503
  • Número del evento
    2008EBC-0001989
  • Fecha
    2016-11-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=115
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has detected the existence of an error in the software that affects the timer function, setting it up without user intervention, which may lead to the occurrence of potentially serious adverse events on the user.
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