Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use Connector detachment during use can deprive patient of adequate ventilation and require immediate medical intervention. Posted 10/20/2016 Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients The FDA is concerned that health care providers may be unaware of the risks associated with these devices. Posted 10/20/2016 Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event. Posted 10/18/2016 Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue User may not be able to connect electrodes to Welch Allyn AED model 10 defibrillator, which may result in a delay in delivering the electrical therapy. Posted 10/14/2016 Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection. Posted 10/13/2016 Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected In some cases full battery drainage can occur within a day to a few weeks after patient receives ERI alert. If battery runs out, ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death. Posted 10/11/2016
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Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations
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