Medical Devices

2018 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.

2018 Safety Communications

Medical Device Safety CommunicationDate
The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication 12/10/18
Use Caution with Implanted Pumps for Intrathecal Administration of Medicines for Pain Management: FDA Safety Communication 11/14/18
The FDA Warns Against the use of Many Genetic Tests with Unapproved Claims to Predict Patient Response to Specific Medications: FDA Safety Communication 11/01/18
UPDATE: Potential Eye Damage from Alcon CyPass Micro-Stent Used to Treat Open-Angle Glaucoma: FDA Safety Communication 10/24/18
Increased Risk of Corneal Haze Associated with the Raindrop Near Vision Inlay: FDA Safety Communication 10/23/18
Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems: FDA Safety Communication 10/19/18
Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication 10/11/18
Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication 09/27/18
Mammography Problems at Aims Diagnostic Imaging in Manahawkin, NJ: FDA Safety Communication 09/24/18
Potential Eye Damage From Alcon CyPass Micro-Stent Used to Treat Open-Angle Glaucoma: FDA Safety Communication 09/14/18
FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication 07/30/18
UPDATE: Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication 07/25/18
Update: Availability of Deep-Cleaning Service of Certain LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stӧckert 3T Heater-Cooler Systems in the U.S.: FDA Safety Communication 06/12/18
Recommendations to Reduce Surgical Fires and Related Patient Injury: FDA Safety Communication 05/29/18
Battery Performance Alert and Cybersecurity Firmware Updates for Certain Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication 04/17/18
UPDATE: Use of Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing of Certain Duodenoscopes: FDA Safety Communication 04/10/18
Updated Status of Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication 02/07/18
Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication 01/17/18
Problem with Quality of Mammograms at Palm Beach Broward Medical Imaging Center in Deerfield Beach, Florida: FDA Safety Communication 01/03/18

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Page Last Updated: 12/10/2018
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