Tecnología Médica

Tecnología Médica

Modular Cathcart Fracture Head
24/06/2022 - During an internal review, it was determined that the Cathcart head includes a +5mm offset, which was not specified in previous versions of the self-centering bipolar and Modular Cathcart unipolar...
Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure
24/06/2022 - The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging.
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)
22/06/2022 - The FDA is issuing this safety communication to alert health care providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac...
Alerta 3877 (Tecnovigilância)
10/06/2022 - Comunicado da empresa Cardinal Health do Brasil - Stent Periférico Palmaz Genesis - possibilidade de deslocamento do stent - Recolhimento. Destruição.
Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect
09/06/2022 - Medtronic recalls pump implant kit due to a pump weld defect that may lead to corrosion of pump internal parts and cause the pump to rotate incorrectly.
Cobalt and Crome Mri Surescan
06/06/2022 - A software update for Carelink Smartsync™ device managers (Smartsync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter...
Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm
06/06/2022 - The iCast catheter-placed stent supports the walls of structure within the body. The balloon or catheter hub may separate during removal, causing harm to the patient.
Alerta 3869 (Tecnovigilância)
03/06/2022 - Comunicado da empresa Abbott Laboratórios do Brasil LTDA - Absolute Pro LL Self-Expanding Stent - relatos de bloqueio mecânico e de falhas de implantação total ou parcial do stent. Aviso de...
Straight Rod - TI
02/06/2022 - On 03/17/2022, a Stryker spine operator packaging non-sterile Yukon Straight Rods from finished goods inventory discovered a Yukon Straight Rod 120 mm (cat#7601-540120, lot# pcmw) with orange and...
Alerta 3853 (Tecnovigilância)
05/05/2022 - Comunicado da empresa Medtronic Comercial Ltda - Heartware - Sistema de Assistência Ventricular – Casos relatados de suspeita de trombose na bomba - Comunicação aos clientes.
Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers
29/04/2022 - The FDA is issuing this letter to ensure you are aware of this defect and the recommended actions to take to manage the care of patients currently implanted with a Medtronic HVAD...
Alerta 3831 (Tecnovigilância)
20/04/2022 - Comunicado da empresa Auto Suture do Brasil LTDA - Neuroestimulador Implantável Percept PC com Tecnologia BrainSense - Falhas na comunicação do aparelho com o programador do...
Alerta 3828 (Tecnovigilância) Atualização
20/04/2022 - Comunicado acerca de certificado de conformidade da empresa Parts Import Comércio de Imp. e Exp. Ltda. Prótese Mamária ISD Texturizada. Segregação e...
Updated safety review of breast implants underscores the continuing importance of monitoring for cancer; increased risk with highly textured (macro-textured) implants
07/04/2022 - Health Canada has updated its 2019 and 2017 safety reviews on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare but serious cancer of the immune system that can develop...
Breast Implants - Summary Safety Review
07/04/2022 - A summary safety review for Breast Implants and the possible risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma is now available.
Alerta 3818 (Tecnovigilância)
04/04/2022 - Comunicado da empresa CRM Comércio Importação e Exportação Ltda - Prótese Mamária com Gel de Silicone – Produto sem o certificado Inmetro de...
Alerta 3813 (Tecnovigilância)
04/04/2022 - Comunicado da empresa ST. Jude Medical Brasil Ltda. - Programador 3650 - anomalia no software do programador. Correção em Campo. Atualização de software.
Indeflator Device
01/04/2022 - Devices from these lots may exhibit leaks and/or a loose connection at the rotating luer assembly or stopcock connection, which could lead to air ingress under vacuum. Analysis indicates an estimated...
Alerta 3809 (Tecnovigilância)
29/03/2022 - Comunicado da empresa Intermedic Technology Importação e Exportação Ltda. - Sistema de Placas Anatômicas de Pequenos e Grandes Fragmentos com Estabilidade Angular...
Alerta 3795 (Tecnovigilância)
23/03/2022 - Comunicado da empresa Getinge do Brasil - Stent para Artérias Periféricas - Tempo para desinflar acima do especificado nas Instruções de Uso - Atualização...
La AEMPS informa sobre el robo de unidades del implante de relleno “Hyamira Forte”
16/03/2022 - Las autoridades sanitarias de Italia han notificado a la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) el robo de un lote del implante de relleno “Hyamira...