German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
Notas adicionales en la data
Source: NCAR
Causa
Device failure / feature before use - material / component.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
Notas adicionales en la data
Source: FSCA
Causa
Device failure / feature before use - manufacturing.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Notas adicionales en la data
Acción
Afssaps was informed on 15/11/10 of the implementation of a batch recall carried out by the company Penumbra. The affected users have received the attached mail (13/12/2010) (27 KB). Only one institution is affected by this recall.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
Notas adicionales en la data
Source: NCAR
Causa
Device failure / feature before use - material / component.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: recall of carefusion nicolet® cortical stimulator control unit, nicolet® c64 stimulus switching unit (ssu) amplifier and nicoletone software with cortical stimulator license
medical device manufacturer, carefusion corporation, is conducting a voluntary recall of nicolet® cortical stimulator control unit, nicolet® c64 stimulus switching unit (ssu) amplifier and nicoletone software with cortical stimulator license.
carefusion has identified potential risks associated with the cortical stimulator control unit, ssu amplifier and related software applications. affected units have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the cortical stimulator control unit screen and in the associated report. the united states food and drug administration (fda) has classified this action as a class i recall.
according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website:
http://www.Fda.Gov/safety/recalls/ucm288493.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
Notas adicionales en la data
Source: NCAR
Causa
Device failure / feature before use - material / component.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: vycor medical viewsite brain access system
the food and drugs administration (fda), united states posted a medical device safety alert concerning viewsite brain access system (vbas) 17mm/ 11mm / 5cm device [model no: tc171105; lot no.: vm83450], manufactured by vycor medical, inc.
according to the report, the manufacturer recalled their vbas because an unidentified black fiber was found on the device.
for details, please visit the following fda website:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?
action=select&recall_number=z-0673-2013&w=01232013&lang=eng
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 25 january 2013.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Medtronic safety note for deep brain stimulation electrode kits (DBS ™)
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: medtronic deep brain stimulation lead kits and dystonia kits
medical device manufacturer, medtronic international limited issued a medical device safety alert concerning the following products:
deep brain stimulation (dbs) lead kits: models 3387, 3387s, 3389, 3389s, 3391, 3391s
dystonia kits: models 3317, 3319, 3337, 3339
medtronic has received reports of dbs leads being damaged at the connector end of the lead when the lead cap is used. tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. if this happens, the damage would most likely occur at lead contact no.3 which could affect electrode contact no.3.
medtronic further explained that depending on the extent of lead damage and the need to use electrode no.3, lead replacement may be required or optimal therapy may not be provided. lead damage due to setscrew connector block twisting has been reported with 0.25% of the dbs leads distributed, however, this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported and the actual number of uses of lead caps is unknown.
according to the manufacturer, there have been no reports of permanent patient impairment, life-threatening injury, or death as a result of this issue.
medtronic is working on corrective actions to reduce the occurrence of setscrew connector block twisting which may result in lead damage. physicians are reminded that every use of the lead cap provides an opportunity for lead damage to occur.
the local supplier confirmed that the affected products have been distributed in hong kong. they will send a letter to relevant physicians to inform them of the risk of lead damage and the actions that should be taken to mitigate occurrence.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 18 february 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ad-tech medical instrument macro micro subdural electrodes
the united states food and drug administration (fda) has posted a press release issued by medical device manufacturer, ad-tech medical instrument corporation, concerning its global recall of macro micro subdural electrodes. the recalled products were manufactured from june 2006 to march 2012, and distributed from 8 june 2006 to 14 march 2012.
on 18 december 2012, the manufacturer initiated a recall of 115 macro micro subdural electrodes. there is a concern the microelectrodes are not flush with the silastic surface. as a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity. there has been one reported serious injury that may have been related to the use of the device.
the manufacturer has notified its distributors and customers by recall letter and is arranging for the return of all available recalled product(s).
for details, please visit the following fda website:
http://www.Fda.Gov/safety/recalls/ucm341680.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 01 march 2013.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 Poland.
Notas adicionales en la data
Acción
Brainlab AG safety note regarding the cranial navigation system
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 inaccuracies in the intraoperative use of the Brainlab Brain Navigation System, manufactured by Brainlab AG, Germany.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding a device removal. 3rd Party Publications