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
UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication	11/05/19
Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication	10/28/19
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