Meeting Notice: March 17, 2017 Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-0001] Joint Meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee and the Risk Communication Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory…

Medrad Intego PET Infusion System Source Administration Sets by Bayer: Corrective Action

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Medrad Intego PET Infusion System Source Administration Sets by Bayer: Recall

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Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication

[Posted 01/11/2017] AUDIENCE: Cardiology, Surgery, Emergency Medicine, Radiology ISSUE: The FDA has received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the MR environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g.,…

Class I Medical Device Recall: Bayer Recalls Medrad Intego PET Infusion System Source Administration Sets due to Particulates Generated in Vial

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Safety Concerns with Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication

Date Issued: January 11, 2017 Audience: Patients who have an implantable infusion pump Caregivers of patients with an implantable infusion pump Health care providers who treat or manage the care of patients with implantable infusion pumps Health care providers and MR technologists involved in the magnetic resonance imaging of patients with implantable infusion pumps Specialties:…

Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication

[Posted 01/09/2017] AUDIENCE: Cardiology, Surgery, Family Practice, Patient ISSUE: The FDA is providing information and recommendations regarding St. Jude Medical’s radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter to reduce the risk of patient harm due to cybersecurity vulnerabilities. The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical’s Merlin@home…

Cybersecurity Vulnerabilities Identified in St. Jude Medical's Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication

Date Issued: January 9, 2017 Audience: Patients with a radio frequency (RF)-enabled St. Jude Medical implantable cardiac device and corresponding Merlin@home Transmitter Caregivers of patients with an RF-enabled St. Jude Medical implantable cardiac device and corresponding Merlin@home Transmitter Cardiologists, electrophysiologists, cardiothoracic surgeons, and primary care physicians treating patients with heart failure or heart rhythm problems…

Meeting Notice: February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. SUMMARY:  The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of…