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 Communication	Date
FDA Warns Against Use of Teething Necklaces, Bracelets, and Other Jewelry Marketed for Relieving Teething Pain or Providing Sensory Stimulation: FDA Safety Communication	12/20/18
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 (Updated 03/05/19)	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	09/27/19
Mammography Problems at Aims Diagnostic Imaging in Manahawkin, NJ: FDA Safety Communication	09/25/18
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) StÓ§ckert 3T Heater-Cooler System 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