Medical Devices

Safety Communications

 

Medical Device Safety Communications

Medical Device Safety CommunicationDate
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 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 (English) 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 (en Español) 01/05/16
FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication 12/23/15
Risk of Eye and Skin Injuries from Hand-held Laser Pointers: FDA Safety Communication 12/22/15
Lubricious Coating Separation from Intravascular Medical Devices: FDA Safety Communication 11/23/15
FDA Recommends Health Care Facilities Transition from Custom Ultrasonics Endoscope Washer/Disinfectors to Alternate Reprocessing Methods: FDA Safety Communication [ARCHIVED] 11/13/15
Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication 10/15/15
Cranial Perforators with an Automatic Clutch Mechanism, Failure to Disengage: FDA Safety Communication 09/28/15
Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication 09/17/15
Serious Adverse Events with Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication 08/05/15
Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication 08/04/15
Cybersecurity Vulnerabilities of Hospira Symbiq Infusion System: FDA Safety Communication 07/31/15
Use of LARIAT Suture Delivery Device for Left Atrial Appendage Closure: FDA Safety Communication 07/13/15
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication 05/28/15
Vulnerabilities of Hospira LifeCare PCA3 and PCA5 Infusion Pump Systems: FDA Safety Communication 05/13/15
Problem with Quality of Mammograms at J. Bruce Jacobs M.D., Inc., doing business as Huntington Radiology in Huntington Park, California: FDA Safety Notification 04/13/15
Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA Safety Communication 03/26/15
Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication 02/19/15
Use of Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients under Age 18 – FDA Safety Communication 01/21/15
UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication 11/24/14
Adverse Events Associated with Use of Enhancement Medical's "Expression" Intranasal Splint as a Dermal Filler 08/05/14
Mammography Problems at Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication 06/23/14
Product Shortage of Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication 05/23/14
Removing Retrievable Inferior Vena Cava Filters: FDA Safety Communication 05/07/14
Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results: FDA Safety Communication 04/29/14
Breast Cancer Screening - Nipple Aspirate Test Is Not An Alternative To Mammography: FDA Safety Communication 12/12/13
Philips HeartStart Automated External Defibrillators (AED): FDA Safety Communication 12/03/13
Rare Serious Erosion Events Associated with St. Jude Amplatzer Atrial Septal Occluder (ASO): FDA Safety Communication 10/17/13
Mammography Problems at San Sebastian X-Ray in San Sebastian, Puerto Rico: FDA Safety Communication 06/27/13
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication 06/13/13
Stolen Covidien Surgical Stapler Reloads: FDA Safety Communication 05/07/13
Damaged or Worn Covers for Medical Bed Mattresses Pose Risk of Contamination and Patient Infection: FDA Safety Communication 04/19/13
Neptune 1 Silver Waste Management System and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Updated FDA Safety Communication 03/27/13
Metal-on-Metal Hip Implants: FDA Safety Communication 01/17/13
Reports of Anaplastic Large Cell Lymphoma (ALCL) in Women with Breast Implants: FDA Safety Communication 01/26/11
FDA Safety Notification: Risk of Eye and Skin Injuries from High-powered, Hand-held Lasers Used for Pointing or Entertainment 12/16/10

Medical Device Safety Archive

The articles, patient alerts, safety communications and public health notifications in the sections below are no longer being reviewed or updated. The information in them may no longer be correct. Items that have been replaced will have a link to up-to-date information

Page Last Updated: 08/25/2016
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