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

Summaries of medical device recalls that may potentially present significant risks to consumers or users of the product.

Recent Letters to Health Care Providers

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

Device NameDate
UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 03/15/19
Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers 03/08/19
Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers 02/06/19
Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers 02/04/19
Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers 01/17/19
Update Regarding Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry 11/08/18
Update Regarding Unintended Heating Associated with the Monteris Medical NeuroBlate Probe 11/08/18
Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers 11/01/18

Page Last Updated: 04/15/2019
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