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  • Dispositivo 4199
  • Fabricante 4199
  • Evento 4307
  • Implante 0
Retiro De Equipo O Alerta De Seguridad para Pseudophakic intraocular lenses AddOn, spherical, hyd...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-03-02
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Cessation of the use and withdrawal from the market of certain spherical pseudophakic intraocular lenses AddOn spherical, reference A4SW00, manufactured by 1stQ GmbH, Germany
Retiro De Equipo O Alerta De Seguridad para Original product: "Futuro brand arm sling" (Reference...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-01-23
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Detection of the sale of counterfeit units of the product "Cabestrillo de Brazo marca Futuro" of the company 3M, in the province of Madrid.
Retiro De Equipo O Alerta De Seguridad para All batches of the Glycine Prophylaxis Powder with TC...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-06-08
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal of Glycine Prophylaxis Powder from TCP ClinproTM, manufactured by 3M Deutschland GmbH, Germany
Retiro De Equipo O Alerta De Seguridad para Lots EJ8UG, EL1WH and EL6CW of the kit "Transbond ™ I...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-06-25
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Removal from the market of certain batches of the "Transbond ™ IDB Pre-Mix Chemical Cured Adhesive" kit, manufactured by 3M Unitek Corporation, USA.
Retiro De Equipo O Alerta De Seguridad para IRIDICA MS1, reference 8N26-90 and serial number AN15...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-06-23
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of obtaining false negative or false positive results with certain references of the IRIDICA system, manufactured by Abbot Molecular Inc, United States.
Retiro De Equipo O Alerta De Seguridad para Software of IRIDICA Controller, version 2.1be instrum...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-04-06
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of obtaining incorrect results with the IRIDICA systems, manufactured by Abbot Molecular Inc, United States, due to a problem with version 2.1b of the IRIDICA Controller software that affects the IRIDICA BB instrument.
Retiro De Equipo O Alerta De Seguridad para ARCHITECT STAT Troponin-I, reference number 2K41-28, ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-05-11
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal from the market of lot 74264UN11 of the reagent ARCHITECT STAT Troponin-I, manufactured by Abbott, (USA), due to the possibility of showing in some cases a deviation in the expected results.
Retiro De Equipo O Alerta De Seguridad para Architect Toxo IgG reagent, reference 6C19-25, lots 1...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2012-08-23
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Removal from the market of certain batches of the Architect Toxo IgG reagent, manufactured by Abbott, Germany, due to the fact that they show a decreased specificity so that results of falsely reactive patient samples could be generated.
Retiro De Equipo O Alerta De Seguridad para ARCHITECT Intact PTH Assay, Reference number 8K25, Re...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-03-10
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal from the market of certain batches of the "ARCHITECT Intact PTH Assay" test reference number 8K25, manufactured by Abbott, Germany, because they can generate falsely high results in patient samples.
Retiro De Equipo O Alerta De Seguridad para Controls ARCHITECT EBV VCA IgM, part number 3P66-10, ...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-06-09
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    The positive control of batch 38938LI00 of the ARCHITECT EBV VCA IgM controls, manufactured by Abbot, Germany, presents a reduced stability, which may generate a higher than expected number of results outside the specified range
Retiro De Equipo O Alerta De Seguridad para ARCHITECT Anti-HBc II Reagent Kit
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-03-05
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Cessation of the use of certain references and batches of the ARCHITECT Anti-HBc II Reagent Kit, manufactured by Abbott, Germany, due to the possibility of falsely reactive results being obtained in patient samples
Retiro De Equipo O Alerta De Seguridad para ARCHITECT Toxo IgM assay.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-11-22
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Increase in results in the gray area and / or falsely reactive results with certain references and batches of the Toxo IgM ARCHITECT assay, manufactured by ABBOTT, Germany, in samples from immunosuppressed or newborn patients, and in umbilical cord samples.
Retiro De Equipo O Alerta De Seguridad para AVEA fans
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-06-05
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possible risk in certain AVEA Ventilators, manufactured by CareFusion Respiratory Systems, USA, caused by a malfunction of a pressure transducer.
Retiro De Equipo O Alerta De Seguridad para "Reactor Buckets of Architect Analyzers", Order No. 7...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-01-03
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal of certain batches from the "Architect Analyzer Reaction Buckets", reference no. 7C15-01, because interaction with any batch of the "Architect 25-OH Vitamin D" test, reference number 3L52 may occur
Retiro De Equipo O Alerta De Seguridad para Reagent ARCHITECT Testosterone, references 7K73-20 an...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-02-21
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    The labels and instructions for use of the ARCHITECT Testosterone test, manufactured by Abbott Ireland Diagnostic Division, Ireland, do not contain warnings and safety precautions on material containing methylisothiazolones.
Retiro De Equipo O Alerta De Seguridad para Reagent ARCHITECT STAT High Sensitive Troponin-I, lot...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-03-07
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Cessation of the use of batch 56940UI00 of the reagent ARCHITECT STAT High Sensitive Troponin-I, reference no. 3P25-26, manufactured by Abbott Ireland Diagnostics Division, Ireland, due to an increase in calibration failures.
Retiro De Equipo O Alerta De Seguridad para ARCHITECT Estradiol assay reference 07K72.
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-04-13
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Cross-reactivity of the drug Fulvestrant (Faslodex®) with the ARCHITECT Estradiol ref. 7K72, manufactured by Abbott Ireland Diagnostics Division, Ireland, whereby falsely elevated estradiol results could be obtained.
Retiro De Equipo O Alerta De Seguridad para Phosphorus reagent, reference numbers 7D71-22 and 7D7...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-09-05
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Error in the expiration date indicated on the labeling of certain batches of the phosphorus reagent, reference numbers 7D71-22 and 7D71-31, manufactured by Abbott Laboratories, USA
Retiro De Equipo O Alerta De Seguridad para Lot 18439M503 of the reagent "AxSYM Valproic acid", r...
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-11-12
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Withdrawal from the market of lot 18439M503 of the reagent "AxSYM Valproic acid", reference number 07A71-20, manufactured by Abbott Laboratories, USA.
Retiro De Equipo O Alerta De Seguridad para Reagent of Clinical Chemistry Lipase
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2014-05-19
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility of erroneous results when using the Lipase Clinical Chemistry reagent in the ARCHITECT c8000 and c4000 systems, manufactured by Abbott Laboratories (USA), due to incorrect information in the instructions for use.
Retiro De Equipo O Alerta De Seguridad para Alkaline wash solution (Alkaline Wash
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2015-06-02
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Removal of lot 49059UN14 from the alkaline wash solution (Alkaline Wash), manufactured by Abbott Laboratories, United States, due to the presence of leaks or loose plugs.
Retiro De Equipo O Alerta De Seguridad para CELL-DYN Emerald cleaner, reference 09H46-02
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2016-04-06
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Cessation of the use of certain batches of CELL-DYN Emerald cleaning reagents, manufactured by Abbott Laboratories, USA, because they could generate quality control results below the range of acceptable values ​​for the RBC and PLT parameters.
Retiro De Equipo O Alerta De Seguridad para Ureteral stent of various lengths
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2017-01-27
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Inclusion of new warnings in the instructions for the use of certain ureteral stent of various lengths, manufactured by Bard Medical Division, USA.
Retiro De Equipo O Alerta De Seguridad para Seeker® crossing support catheter
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-01-17
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Incorrect labeling in certain references and batches of the Seeker® crossing support catheter, manufactured by Bard Peripheral Vascular, USA.
Retiro De Equipo O Alerta De Seguridad para Lot REWE1689 of the Magnum ™ biopsy needle, code MN1410
  • Tipo de evento
    Recall / Safety Alert
  • Fecha
    2013-07-01
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Removal from the market of the REWE1689 batch of the Magnum ™ biopsy needle, code MN1410, manufactured by Bard Peripheral Vascular, USA, due to the possibility that the needle has a longer length than that indicated on the label.
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