Medical Devices

2016 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.

2016 Safety Communications

Medical Device Safety CommunicationDate
FDA Warns Health Care Providers Against Relying Solely on Zika Virus Serological IgM Assay Results; Reminds them to Wait for Confirmatory Test Results Before Making Patient Management Decisions: FDA Safety Communication 12/22/16
La FDA advierte a los proveedores de atención médica que no deben basarse únicamente en los resultados de la prueba serológica de IgM frente al virus del Zika; les recuerda que esperen los resultados de la prueba de confirmación antes de decidir el tratamiento del paciente: Comunicación de Seguridad de la FDA (en Español) 12/13/16
UPDATE: Mycobacterium chimaera Infections Associated with LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler System: FDA Safety Communication 10/13/16
Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication 10/11/16
The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication 09/07/16
Incorrect Assignment of Test Results Associated with Sciex Mass Spectrometers: FDA Safety Communication 09/01/16
Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences: FDA Safety Communication 08/25/16
FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing Duodenoscopes; These Reprocessors Remain Available to Reprocess Other Flexible Endoscopes: FDA Safety Communication 08/17/16
Mycobacterium chimaera Infections Associated with Sorin Group Deutschland GmbH Stӧckert 3T Heater-Cooler System: FDA Safety Communication [ARCHIVED] 06/01/16
The FDA Recommends Against Using OxySure Portable Emergency Oxygen System, Model 615: FDA Safety Communication 03/29/16
Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication 03/15/16
Neurosurgical Head Holders (Skull Clamps) and Device Slippage: FDA Safety Communication 02/25/16
PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication 02/19/16
The FDA Recommends Health Care Providers Stop Using Customed, Inc. Surgical Convenience Packs and Trays: FDA Safety Communication 01/05/16
La FDA le recomienda a los proveedores de servicios de salud detener el uso de los paquetes y bandejas con material quirúrgico de Customed, Inc.: Comunicación de Seguridad de la FDA 01/05/16

Page Last Updated: 05/23/2017
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