Medical Devices

2017 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.

2017 Safety Communications

Medical Device Safety CommunicationDate
Firmware Update to Address Cybersecurity Vulnerabilities Identified in Abbott's (formerly St. Jude Medical's) Implantable Cardiac Pacemakers: FDA Safety Communication 08/29/17
Updated Status of FUJIFILM Medical Systems, U.S.A., Inc. Model ED-530XT Duodenoscopes: FDA Safety Communication 07/21/17
Navigational Accuracy Errors Associated with Frameless Stereotaxic (Stereotactic) Navigation Systems: FDA Safety Communication 06/15/17
FDA Warns Against Using Magellan Diagnostics LeadCare Testing Systems with Blood Obtained from a Vein: FDA Safety Communication 05/17/17
FDA Warns Of Potentially Contaminated SPS-1 Static Preservation Solution Distributed by Organ Recovery Systems, Inc.: FDA Safety Communication 03/09/17
FDA concern over experimental procedures that use balloon angioplasty devices to treat autonomic dysfunction: FDA safety communication 03/08/17
UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication 01/17/17
FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication 01/13/17
Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication 01/11/17
Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication 01/09/17

Page Last Updated: 08/29/2017
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