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  • Dispositivo 3309
  • Fabricante 731
  • Evento 124969
  • Implante 166
Retiro De Equipo (Recall) de CS100I INTRA AORTIC BALLOON PUMP
  • Tipo de evento
    Recall
  • ID del evento
    86189
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-06-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Maquet/getinge has received a complaint involving a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail) maintenance code #3 and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. an electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. the lack of power prevents the coil from moving the plunger causing the valve not to open. this is recognized by the system as an electrical test failure code #58 upon powering on the iab. units distributed after december 11 2013 are not affected by the field correction.
Retiro De Equipo (Recall) de PULSAR-18 PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    86197
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-05-22
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Manufacturer received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of pulsar-18 peripheral self-expanding nitinol stent system.
Retiro De Equipo (Recall) de LIFEPAK 500 AUTOMATIC EXTERNAL DEFIBRILLATOR
  • Tipo de evento
    Recall
  • ID del evento
    86218
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-07-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Manufacturer has received reports of lithium diode batteries having a potential to malfunction due to battery cell rupture which could cause user and patient injury and repair before can be used.
Retiro De Equipo (Recall) de CURVED CANNULA ARM 1 (DA VINCI SI)
  • Tipo de evento
    Recall
  • ID del evento
    86222
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-03-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Potential for certain lots of cannulae to become damaged when the cannulae are not coorectly placed in single-site port.
Retiro De Equipo (Recall) de INVISITRACE ECG ELECTRODE
  • Tipo de evento
    Recall
  • ID del evento
    86228
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2003-10-08
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    There have been reports that some electrodes in these lots may exhibit a separation of the sensing element from the body of the electr causing the electrode not to function. no injuries occur.
Retiro De Equipo (Recall) de EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGM CAPTURE ELISA KIT
  • Tipo de evento
    Recall
  • ID del evento
    86234
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-03-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Device has demonstrated reduced stability.
Retiro De Equipo (Recall) de MIO INFUSION SETS
  • Tipo de evento
    Recall
  • ID del evento
    86242
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-09-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. the reported incidence rate requiring medical assistance related to thisissue is less than 1 in every 2 million infusion sets. over-delivery of insulin can cause hypoglycemia and in extreme cases death. medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. manufacturer investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid may occur if insulin alcohol or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. infusion sets currently being shipped by medtronic contain a new and enhanced membrane material that significantly reduces this risk.
Retiro De Equipo (Recall) de MAGNETOM VISION PLUS
  • Tipo de evento
    Recall
  • ID del evento
    86327
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2000-08-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    To correct software problems.
Retiro De Equipo (Recall) de KODAK ULTRA-SPEED DENTAL FILM DF54 POLY SOFT
  • Tipo de evento
    Recall
  • ID del evento
    86250
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-08-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Incorrect name on the end panels of the carton of some lots of kodak ultra-speed dental film item 122 8840 (size 0 single film packet) df54. on the cartons where this error appears the word "insight" is incorrectly printed instead of "ultra-speed". the product inside the carton is true kodak ultra-speed film and all other labeling on the package is correct. the only error is the use of the word "insight" instead of "ultra-speed" on the end panels.
Retiro De Equipo (Recall) de MICROTARGETING - OPTIONS
  • Tipo de evento
    Recall
  • ID del evento
    86259
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-10-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The micro-electrode may continue to advance even when the remote control knob is released.
Retiro De Equipo (Recall) de LCX PROBE SYSTEM NEISSERIA GONORRHEA ASSAY (AMPLIFICATION)
  • Tipo de evento
    Recall
  • ID del evento
    86260
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2002-07-31
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Manufacturer has determined that the lots may not meet the analytical sensitivity) limit of dtection) of 10 colony forming units as decribed in the product insert.
Retiro De Equipo (Recall) de REAMING ROD W/BALL TIP
  • Tipo de evento
    Recall
  • ID del evento
    86264
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-07-26
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    During an open peel test it was identified that the seals for a reaming rod sealed in packaging aids corporation jaw sealer machine had gaps/channeling in the seals therefore resulting in the potential for non-sterile product. recall initiated due to potential gaps/channeling in the seal of the package.
Retiro De Equipo (Recall) de MICRO-JEWEL ACTIVE CAN ELECTRODE ARRHYTHMIA MANAGEMENT DEVICE
  • Tipo de evento
    Recall
  • ID del evento
    86280
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-04-23
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de ARTIS Q
  • Tipo de evento
    Recall
  • ID del evento
    86286
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    As part of regular post market surveillance activities siemens discovered an error in the 19" live display such that image reproduction may fail in the examination room. the loss of image can only occur immediately after system startup. this failure does not occur during normal operation or when the live image is displayed. only systems which use a live display (reference dshc1914-dc with part number 10656055) in the examination room are affected. live displays with other part numbers are not affected by this issue.
Retiro De Equipo (Recall) de ARCHITECT SYSTEM - IRON ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    86299
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-04-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    It was identified that an incorrect magnesium cal 2 calibrator value (cal 2) was provided for one lot. the value is labeled as 3.2 meq/l but should be 3.7 meq/l.
Retiro De Equipo (Recall) de LIFE BRAND DIGITAL TEMPLE THERMOMETER
  • Tipo de evento
    Recall
  • ID del evento
    86320
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2015-12-03
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The main issue for the product is that it was not calibrated properly and may give inaccurate temperature readings. as such a person using this may not realize the severity of a temperature. we were informed of this issue as a result of a recall in the united states.
Retiro De Equipo (Recall) de FORTE EPIC HP CAMERA WITH 5/8 CRYSTAL AND MCD
  • Tipo de evento
    Recall
  • ID del evento
    86328
  • Clase de Riesgo del Evento
    II
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Collimator drawer could drop.
Retiro De Equipo (Recall) de SERVO 300 SERVO VENTILATOR 300
  • Tipo de evento
    Recall
  • ID del evento
    86358
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1998-08-20
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Gas module for no has the potential to fail premeturly.
Retiro De Equipo (Recall) de INTOUCH CRITICAL CARE BED
  • Tipo de evento
    Recall
  • ID del evento
    86383
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-07-03
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Stryker received complaints which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. if more than one caster on a unit is damaged brake functions may be affected and result in reduced brake holding force. if only one caster on the bed is damaged brake functionality continues to meet specifications.
Retiro De Equipo (Recall) de CALASEPT
  • Tipo de evento
    Recall
  • ID del evento
    86413
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-03-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Product has not received market authorization for sale in canada.
Retiro De Equipo (Recall) de NEPTUNE 2 WASTE MANAGEMENT SYSTEM - ROVER
  • Tipo de evento
    Recall
  • ID del evento
    86425
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-07-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Stryker instruments has received reports of casters failing in the field. the caster failures have resulted from the "swivel head of the caster which is a double ball bearing composed of polyamide that loosens over time" creating excessive swivel play. the resultant swivel play allows the caster to bind/jam with the chassis of the rover when force is applied by the operator to move the device.
Retiro De Equipo (Recall) de TENSOR SPORTS TAPE
  • Tipo de evento
    Recall
  • ID del evento
    86437
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-07-29
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Products contain dry natural rubber material were not labelled with appropriate caution statement.
Retiro De Equipo (Recall) de BD VACUTAINER LUER-LOK ACCESS DEVICE
  • Tipo de evento
    Recall
  • ID del evento
    86438
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2006-09-13
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Issues relating to blood leackage and air introduction into the evacuated tube during the drawing process.
Retiro De Equipo (Recall) de VALTRAC BIOFRAGMENTABLE ANASTOMOSIS RINGS
  • Tipo de evento
    Recall
  • ID del evento
    86446
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-06-03
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de GAMMAMED 12I GAMMA IRRADIATION INSTRUMENT
  • Tipo de evento
    Recall
  • ID del evento
    86468
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-02-06
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Software error that lead to incorrect factor transmitted to the gammamed and the computer used the wrong factor to calculate the treatment time.
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