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  • Dispositivo 26
  • Fabricante 14
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Waterlase MD
  • Tipo de evento
    Recall
  • ID del evento
    31106
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0543-05
  • Fecha de inicio del evento
    2005-01-17
  • Fecha de publicación del evento
    2005-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-08-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37154
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Laser, Dental - Product Code LYB
  • Causa
    Reports that the waterlase md, a dental laser unit, water bottle broke under pressure during installation.
  • Acción
    Water bottles will be replaced by trained Biolase representatives. During that visit, the representative will verify that the bottle pressure is set correctly and the existing bottle is replaced with a new bottle.
Retiro De Equipo (Recall) de LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 m...
  • Tipo de evento
    Recall
  • ID del evento
    31108
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0557-05
  • Fecha de inicio del evento
    2005-02-07
  • Fecha de publicación del evento
    2005-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37156
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, Embolectomy - Product Code DXE
  • Causa
    Product sterility maybe compromised due to defective packaging.
  • Acción
    LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
Retiro De Equipo (Recall) de LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml,...
  • Tipo de evento
    Recall
  • ID del evento
    31108
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0558-05
  • Fecha de inicio del evento
    2005-02-07
  • Fecha de publicación del evento
    2005-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37157
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, Embolectomy - Product Code DXE
  • Causa
    Product sterility maybe compromised due to defective packaging.
  • Acción
    LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
Retiro De Equipo (Recall) de LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 m...
  • Tipo de evento
    Recall
  • ID del evento
    31108
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0559-05
  • Fecha de inicio del evento
    2005-02-07
  • Fecha de publicación del evento
    2005-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37158
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, Embolectomy - Product Code DXE
  • Causa
    Product sterility maybe compromised due to defective packaging.
  • Acción
    LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
Retiro De Equipo (Recall) de LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 m...
  • Tipo de evento
    Recall
  • ID del evento
    31108
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0560-05
  • Fecha de inicio del evento
    2005-02-07
  • Fecha de publicación del evento
    2005-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37159
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, Embolectomy - Product Code DXE
  • Causa
    Product sterility maybe compromised due to defective packaging.
  • Acción
    LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
Retiro De Equipo (Recall) de Device Recall MicroScan
  • Tipo de evento
    Recall
  • ID del evento
    31125
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0668-05
  • Fecha de inicio del evento
    2005-02-07
  • Fecha de publicación del evento
    2005-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37195
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
  • Causa
    There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.
  • Acción
    The customer notifications were sent to U.S. customers on January 27, 2005 via FedEx. International customers are to be notified by Dade Behring affiliates in the affected countries by February 10, 2005. Follow up will be made via phone call.
Retiro De Equipo (Recall) de Device Recall LIFEPAK
  • Tipo de evento
    Recall
  • ID del evento
    31111
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0562-05
  • Fecha de inicio del evento
    2005-02-03
  • Fecha de publicación del evento
    2005-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37172
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Causa
    Potential to not detect patients at the low end of the patient impedance range.
  • Acción
    On 2/3/05 the firm issued a 'Medical Device Correction' letter dated January 2005 to their customers. The letter advised customers of the issue and stated a representative from the firm would visit each facility to update affected unit. On 2/25/05 a nationwide press release was issued. On 3/1/05 the firm began telephoning each customer, this was followed by another letter titled MEDICAL DEVICE RECALL. The letter advises of the issue and recommends defibrillators remain in service when no alternative is available until the unit can be corrected. Each unit will be replaced or corrected. On 4/22/05 the firm issued another letter, via certified mail return receipt, expanding their recall. Letter was issued to all customers affected by the expansion of the recall. On 4/22/05 the firm issued a press release advising of the expansion of the recall. The firm's web site also provides a listing of affected units.
Retiro De Equipo (Recall) de Device Recall Voyager
  • Tipo de evento
    Recall
  • ID del evento
    31116
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0707-05
  • Fecha de inicio del evento
    2005-01-27
  • Fecha de publicación del evento
    2005-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37178
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stent, Coronary - Product Code MAF
  • Causa
    Leak at guide wire exit notch could introduce air into the artery.
  • Acción
    Firm notified affiliates in foreign countries and distributors of the recall on 01/27/2005. Recall is on-going.
Retiro De Equipo (Recall) de Device Recall LICOX Complete Brain IMC Probe Kit, Model IM3.ST C
  • Tipo de evento
    Recall
  • ID del evento
    31117
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0622-05
  • Fecha de inicio del evento
    2005-01-21
  • Fecha de publicación del evento
    2005-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37179
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Test, Sorbent, Fta-Abs - Product Code GMW
  • Causa
    Licox model c8.B temperature probes manufactured by gms mbh, an integra company, may exhibit progen (endotoxin) levels above the fda limit of 2.15 endotoxin units per device. elevated endotoxin levels may result in an increased patient risk of fever.
  • Acción
    LICOX Model C8.B temperature probes and LICOX IM3.ST Complete Brain IMC Probe Kits manufactured by GMS mbH, an Integra company, may exhibit pyrogen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
Retiro De Equipo (Recall) de Device Recall LICOX C8.B temperature probe, Model 160504 and 240604
  • Tipo de evento
    Recall
  • ID del evento
    31117
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0623-05
  • Fecha de inicio del evento
    2005-01-21
  • Fecha de publicación del evento
    2005-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37180
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Test, Sorbent, Fta-Abs - Product Code GMW
  • Causa
    Licox model c8.B temperature probes manufactured by gms mbh, an integra company, may exhibit progen (endotoxin) levels above the fda limit of 2.15 endotoxin units per device. elevated endotoxin levels may result in an increased patient risk of fever.
  • Acción
    LICOX Model C8.B temperature probes and LICOX IM3.ST Complete Brain IMC Probe Kits manufactured by GMS mbH, an Integra company, may exhibit pyrogen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
Retiro De Equipo (Recall) de Device Recall BioRad
  • Tipo de evento
    Recall
  • ID del evento
    31123
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0659-05
  • Fecha de inicio del evento
    2005-01-25
  • Fecha de publicación del evento
    2005-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-04-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37189
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Antigen, Galactomannan, Aspergillus Spp. - Product Code NOM
  • Causa
    New instructions to recommend against using samples with visibly high level of blood.
  • Acción
    Letters were sent to customers January 25-27, 2005 via overnight mail. Letters advised the customers of the issue and included a new package insert. The firm included a revised package insert to clarify precautions. The firm sent a CORRECTED COPY letter dated January 31, 2005 outlining the changes made in the product insert.
Retiro De Equipo (Recall) de LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 m...
  • Tipo de evento
    Recall
  • ID del evento
    31108
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0561-05
  • Fecha de inicio del evento
    2005-02-07
  • Fecha de publicación del evento
    2005-02-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37192
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, Embolectomy - Product Code DXE
  • Causa
    Product sterility maybe compromised due to defective packaging.
  • Acción
    LaMaitre notified consignees by lettter advising users to check inventory and return defective product.
Retiro De Equipo (Recall) de Device Recall Hydraulic and battery powered patient lifts
  • Tipo de evento
    Recall
  • ID del evento
    31124
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0785-05
  • Fecha de inicio del evento
    2005-02-03
  • Fecha de publicación del evento
    2005-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37193
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Causa
    The leg actuation mechanism on certain hoyer advance patient lifts may not operate properly, which could cause the lift to become unstable.
  • Acción
    Telephone calls were placed to customers on 02/03/05. Urgent Medical Device Correction letters, dated 02/03/05, were also sent to customers.
Retiro De Equipo (Recall) de Device Recall Stereotaxic Navigation System
  • Tipo de evento
    Recall
  • ID del evento
    31133
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0711-05
  • Fecha de inicio del evento
    2005-01-28
  • Fecha de publicación del evento
    2005-04-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37209
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Neurological Stereotaxic Instrument - Product Code HAW
  • Causa
    The stealth station cranial application version 4.5 contains a software anomaly, which may present a hazard to the patient.
  • Acción
    Customers were sent notification letters dated 01/28/05 and 02/02/05.
Retiro De Equipo (Recall) de Tissuelink Dissecting Sealer DS3.5-C, Sterile || Ref 13-121-1
  • Tipo de evento
    Recall
  • ID del evento
    31132
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0563-05
  • Fecha de inicio del evento
    2005-02-07
  • Fecha de publicación del evento
    2005-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37212
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Causa
    The tip may separate from the device and render it unusable.
  • Acción
    TissueLink notified consignees by Federal Express Letter from 2/7/05 to 2/8/05. Users are requested to return devices in inventory.
Retiro De Equipo (Recall) de CryoValve, Aortic Valve & Conduit SG
  • Tipo de evento
    Recall
  • ID del evento
    31140
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0683-05
  • Fecha de inicio del evento
    2004-12-17
  • Fecha de publicación del evento
    2005-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37233
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Heart-Valve, Allograft - Product Code MIE
  • Causa
    During a retrospective review, cryolife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'last seen alive' time in their calculation.
  • Acción
    Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.
Retiro De Equipo (Recall) de CryoValve, Pulmonary Valve and Conduit
  • Tipo de evento
    Recall
  • ID del evento
    31140
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0684-05
  • Fecha de inicio del evento
    2004-12-17
  • Fecha de publicación del evento
    2005-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37234
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Heart-Valve, Allograft - Product Code MIE
  • Causa
    During a retrospective review, cryolife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'last seen alive' time in their calculation.
  • Acción
    Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.
Retiro De Equipo (Recall) de CryoValve, Aortic Valve & Conduit
  • Tipo de evento
    Recall
  • ID del evento
    31140
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0685-05
  • Fecha de inicio del evento
    2004-12-17
  • Fecha de publicación del evento
    2005-04-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37235
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Heart-Valve, Allograft - Product Code MIE
  • Causa
    During a retrospective review, cryolife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'last seen alive' time in their calculation.
  • Acción
    Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.
Retiro De Equipo (Recall) de Device Recall Medtronic Marquis VR
  • Tipo de evento
    Recall
  • ID del evento
    31142
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0597-05
  • Fecha de inicio del evento
    2005-02-09
  • Fecha de publicación del evento
    2005-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37239
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Causa
    Medtronic marquis family of icd and crt-d devices having batteries manufactured prior to december 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
  • Acción
    Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information. The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care.
Retiro De Equipo (Recall) de Device Recall Stryker
  • Tipo de evento
    Recall
  • ID del evento
    31145
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0786-05
  • Fecha de inicio del evento
    2005-02-08
  • Fecha de publicación del evento
    2005-05-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-05-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37241
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Arthroscope - Product Code HRX
  • Causa
    The device has the potential to overheat and cause patient burns during use.
  • Acción
    All consignees will be immediately notified via phone calls and a mailed Urgent Product Recall Notice (2 recipients per consignee, Risk Manager and OR Supervisor)
Retiro De Equipo (Recall) de Device Recall MIRA
  • Tipo de evento
    Recall
  • ID del evento
    31056
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0650-05
  • Fecha de inicio del evento
    2005-02-15
  • Fecha de publicación del evento
    2005-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37242
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Assay, Glycosylated Hemoglobin - Product Code LCP
  • Causa
    The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.
  • Acción
    Recall letters dated 2/15/05 were sent to each user instructing customers to run controls before the use of each cassette or kit in a lot, instead of once per lot as previously instructed, and to notify the physician at the facility.
Retiro De Equipo (Recall) de BioTek brand Automated Microplate Reader; model ELx800, Roche catalo...
  • Tipo de evento
    Recall
  • ID del evento
    31146
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0573-05
  • Fecha de inicio del evento
    2005-02-15
  • Fecha de publicación del evento
    2005-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-05-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37243
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Colorimeter, Photometer, Spectrophotometer For Clinical Use - Product Code JJQ
  • Causa
    The parameters loaded in the analyzer for the hepatitis c virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.
  • Acción
    Recall letters dated 2/15/05 are being sent to each consignee instructing them to discontinue use of pre-programmed HCV parameters with the Amplicor heatitis C virus test and that previous test results within a specific range be reviewed by a physician.
Retiro De Equipo (Recall) de Device Recall Angiographic Syringe
  • Tipo de evento
    Recall
  • ID del evento
    30478
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0619-05
  • Fecha de inicio del evento
    2004-11-02
  • Fecha de publicación del evento
    2005-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37256
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Causa
    Syringes could possibly allow air to enter the patient's vascular system.
  • Acción
    Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
Retiro De Equipo (Recall) de Device Recall Angiographic Syringe
  • Tipo de evento
    Recall
  • ID del evento
    30478
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0620-05
  • Fecha de inicio del evento
    2004-11-02
  • Fecha de publicación del evento
    2005-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37257
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Causa
    Syringes could possibly allow air to enter the patient's vascular system.
  • Acción
    Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
Retiro De Equipo (Recall) de Device Recall Catheterization Kits
  • Tipo de evento
    Recall
  • ID del evento
    30478
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0621-05
  • Fecha de inicio del evento
    2004-11-02
  • Fecha de publicación del evento
    2005-03-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2005-07-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37258
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Catheter, Intravascular, Diagnostic - Product Code DQO
  • Causa
    Syringes could possibly allow air to enter the patient's vascular system.
  • Acción
    Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.