U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Safety Communications
  5. 2019 Safety Communications
  1. 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.

2019 Safety Communications

Device Name Date
URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication 10/01/19
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication 08/29/19
The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication 07/24/19
Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication 06/27/19
FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication 05/17/19
FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication 05/07/19
Mammography Problems at East Palestine Family Medical Clinic in East Palestine, Ohio: FDA Safety Communication 04/26/19
Use of the Stryker Wingspan Stent System Outside of Approved Indications Leads to an Increased Risk of Stroke or Death: FDA Safety Communication 04/25/19
The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication 04/12/19
The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication 04/10/19
The FDA Warns Against Use of Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States: FDA Safety Communication 04/08/19
Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication 03/21/19
UPDATE -- Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Software Update for Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication 03/06/19
Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication 02/28/19
FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer: FDA Safety Communication 02/25/19
Intravascular Air-in-Line and Air Embolism Risks Associated with Infusion Pumps, Fluid Warmers, and Rapid Infusers: FDA Safety Communication 01/31/19

 

 

 

 

 

 

 

Subscribe to Medical Device Safety and Recalls

Sign up to receive email updates on medical device recalls, safety communications, and other safety information.