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  • Dispositivo 2
  • Fabricante 2
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de CAPTURE-R READY-SCREEN 1 AND II
  • Tipo de evento
    Recall
  • ID del evento
    132625
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-03-28
  • 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
    Higher than normal number of false negative tests for anti-fya. potentially implicated in transfusion reaction. see incident 019978.
Retiro De Equipo (Recall) de COBE TRIMA BLOOD COLLECTION SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    132630
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-02-08
  • 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
    Defects may occur during the manufacturing of trima accel tubing sets. it was found during assembly of the ac/draw/return manifold the automated equipment may improperly insert the return line tubing into the manifold in such a way that the tubing maybe bent.
Retiro De Equipo (Recall) de STRAIGHT CONNECTOR
  • Tipo de evento
    Recall
  • ID del evento
    132640
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-08-31
  • 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
    A leak has been found at the shank during priming before perfusion a manufacturer issue was detected at the supplier level.
Retiro De Equipo (Recall) de VISUM 300 CEILING MOUNTED EXAM LIGHT
  • Tipo de evento
    Recall
  • ID del evento
    132643
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-08-02
  • 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 has become aware that there is a remote likelihood of incomplete welds on the drop tube flange of the visum 300 ceiling-mounted exam light.
Retiro De Equipo (Recall) de FLOWPRA CLASS I AND II SCREENING TESTS
  • Tipo de evento
    Recall
  • ID del evento
    132659
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2002-07-11
  • 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
    Sale of unlicensed devices.
Retiro De Equipo (Recall) de WECK AUTO ENDO5 AUTOMATIC HEM-O-LOK CLIP APPLIER
  • Tipo de evento
    Recall
  • ID del evento
    132673
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-10-05
  • 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 devices being recalled are surgical clip appliers that are preloaded for use in minimally invasive surgical procedures. teleflex is recalling these devices because they have a nonconformity that may cause clips to misload jam or fall out of the appliers.
Retiro De Equipo (Recall) de TRINICA ANTERIOR LUMBAR PLATE (ALP) SYSTEM CASE ASSEMBLY
  • Tipo de evento
    Recall
  • ID del evento
    132676
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-10
  • 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
    Zimmer is initiating a device correction for the trinica anterior lumbar plate (alp) system case assembly. the ratchet handles part number 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. this is due to the current bracketing in the tray which may interfere with complete steam penetration into the cannulated handle. to assure effective sterilization the ratchet handles must be sterilized external to the instrument tray until newly designed replacement trays are available.
Retiro De Equipo (Recall) de CUTTING BALLOON RAPID EXCHANGE
  • Tipo de evento
    Recall
  • ID del evento
    132678
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-12-07
  • 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
    Class 4 device sold without a licence.
Retiro De Equipo (Recall) de ABG KIT - ASPIRATOR WITH ALCOHOL PREP PAD AND GAUZE
  • Tipo de evento
    Recall
  • ID del evento
    132683
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2007-02-12
  • 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
    Abg kits outer labels incorrectly identified as containing 200 units of heparin when in fact the 3cc syringe only contains 100 units.
Retiro De Equipo (Recall) de VARIS TREATMENT
  • Tipo de evento
    Recall
  • ID del evento
    132684
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2004-06-14
  • 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 wedge mu is correct after the first treatment at the non-varian machine however after treatment varis may prompt to save and the wedge mu is reset to null for sebsequent sessions.
Retiro De Equipo (Recall) de 12.5F DUO-SPLIT CATHETER SETS
  • Tipo de evento
    Recall
  • ID del evento
    132685
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-07-31
  • 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
    Leak through the pinch/line clamp following insertion. the clamp may not occlude for the three product lines.
Retiro De Equipo (Recall) de SIMPLASTIN EXCEL-S
  • Tipo de evento
    Recall
  • ID del evento
    132686
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2005-08-18
  • 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
    Les valeurs de l'isi publiees dans la notice technique des lots concernes de simplastin excel s sont inexactes pour les instruments fibrometre (mecanique) option xm et mtx (photo optique).
Retiro De Equipo (Recall) de DIMENSION EXL SYSTEM - TOTAL IRON BINDING CAPACITY (IBCT) ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    132690
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-12-21
  • 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
    Through monitoring of method performance siemens has determined that the analytical sensitivity claim of 6.6 mcg/dl (1.1 mcmol/l) stated in the instructions for use is no longer valid for dimension total iron binding capacity (ibct) and is modifying that claim to 36 mcg/dl (6.44 mcmol/l).
Retiro De Equipo (Recall) de ADVIA CENTAUR CP SYSTEM - CALIBRATOR
  • Tipo de evento
    Recall
  • ID del evento
    132703
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-02-16
  • 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
    Siemens healthcare diagnostics has confirmed a lot to lot bias with calibrator e kit for the advia centaur testosterone assay. internal investigation demonstrates: -an average positive bias of 17% across the assay range with calibrator e kit lots ending in 42 as compared to values generated with the master curve. -an average negative bias of 7% across the assay range with calibrator e kit lots ending in 43 as compared to values generated with the master curve. -the positive bias of calibrator e kit lots ending in 42 to the master curve compared to the negative bias of calibrator e kit lots ending in 43 to the master curve is the main driver for the negative bias between values generated with calibrator e kit lots ending in 42 and calibrator e kit lots ending in 43. the bias of the calibrators to the master curve has been corrected with calibrator e kit lots ending in 44. the performance of the testosterone assay on the advia centaur cp is not affected. calibrator e is also used for calibration of the advia centaur systems cortisol and progesterone assays however the performance of these assays is not affected.
Retiro De Equipo (Recall) de SERIES 8000 HOLTER PLAYBACK ANALYSIS SYSTEM & ACCE
  • Tipo de evento
    Recall
  • ID del evento
    132712
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    1997-10-02
  • 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 NEURON MAX 088 LONG SHEATH
  • Tipo de evento
    Recall
  • ID del evento
    132728
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-10-01
  • 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
    Penumbra has become aware of complaints involving devices where the operator complained of damage to the tip of the neuron max mp catheter after removal from the packaging. upon evaluation of the returned devices penumbra confirmed that the polymer at the distal tip of the device had been damaged. further investigation determined that the sticker adhesive used to secure the packaging mandrel to the packaging card was less sticky then previous lots of stickers.
Retiro De Equipo (Recall) de ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFOTAXIME
  • Tipo de evento
    Recall
  • ID del evento
    132729
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2015-06-11
  • 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
    An internal investigation identified a performance deviation associated with quality control testing of retained product samples indeed the qc results were out of range resulting in false resistant strains.
Retiro De Equipo (Recall) de SHER-I-BRONCH ENDOBRONCHIAL TUBE KIT
  • Tipo de evento
    Recall
  • ID del evento
    132730
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-04-25
  • 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
    A limited number of tubes may be mislabelled on the blue bronchial sleeve. the label may incorrectly state "right" when it should state "left" or "left" when it should state "right".
Retiro De Equipo (Recall) de ROBINSON/NELATON CATHETER
  • Tipo de evento
    Recall
  • ID del evento
    132732
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-07-12
  • 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 urology catheters are being recalled because the packaging may be compromised and therefore the sterility of the product cannot be guaranteed.
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