Medical Devices

Medical Device Safety

The FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. The lists below contain our most recent information. Other safety communications can be found using the links on the left side of this page. For additional information, contact us at:  1-800-638-2041 or DICE@fda.hhs.gov.

Recent Medical Device Recalls

Recent Letters to Health Care Providers

Information for health care providers about the safe use of medical devices in medical facilities.

Device NameDate
FDA Investigating Increased Rate of Major Adverse Cardiac Events Observed in Patients Receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) - Letter to Health Care Providers 03/18/17
Neurovascular Thrombus Retrieval Catheters and Guide Catheters Used During Neurological Interventional Procedures: Differences in FDA Review and Intended Use - Letter to Health Care Providers 03/01/17
The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons 02/09/17
Potential Problems with Battery-Powered Mobile Medical Carts in Health Care Facilities that May Result in Fire: Letter to Health Care Professionals 12/27/16
UPDATE: SynCardia Systems - TAH-t Companion 2 Driver System (C2) and Freedom Driver System - Letter to Health Care Providers 10/26/16

Subscribe

Sign up to receive email updates on Medical Device Safety.

Page Last Updated: 05/23/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English