Medical Devices

FDA monitors reports of adverse events and other problems with medical devices, providing alerts and guidance to ensure proper use of devices.  Find various documents related to devices used in long term care facilities in this category.

 
 Date PostedPublication
5/17/2019 Warning Issued Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication 
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5/8/2019 FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Medtronic Pacemakers: FDA Safety Communication 
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4/9/2019 Previously Owned Test Strips or Test Strips Not Authorized for Sale in the United States: FDA Safety Communication 
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3/22/2019 Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication 
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3/8/2019 Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication 
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2/15/2019 Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators Due to Possible Circuit Error 
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2/1/2019 Terrific Care, LLC./Medex Supply Recalls CoaguChek XS PT Test Strips Due to Innacurate Test Results 
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2/1/2019 West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer System due to Potential Malfunctions 
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1/25/2019 Draeger Medical Recall Breathing Circuits and Anesthesia Sets 
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12/20/2018 Medtronic Announces Worldwide Voluntary Field Corrective Action - Software Update Issued for Puritan Bennett 980 Ventilator Series 
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11/15/2018 Implanted Pumps: Use Caution When Selecting Pain Medicine for Intrathecal Administration - FDA Safety Communication 
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10/17/2018 The FDA's Role in Medical Device Cybersecurity 
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10/12/2018 Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication 
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10/1/2018 Caution When Using Pen Needles to Inject Medicines: FDA Safety Communication 
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7/9/2018 Recommendations for Health Care Providers about Bed Rails 
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4/17/2018 Abbott (formerly St. Jude Medical) Implantable Cardiac Devices: FDA Safety Communication 
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3/30/2018 Dexcom G6 - First Fully Interoperable Continuous Glucose Monitoring System 
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1/5/2018 Medtronic MiniMed 670G System 
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12/7/2017 Keeping Patients Safe from Contaminated Mattresses 
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4/11/2017 Clinical Guidance for the Assessment and Implementation of Bed Rails 
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2/14/2017 FDA-Approved Devices that Keep the Heart Beating 
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1/12/2017 Implantable Infusion Pumps in the Magnetic Resonance Environment: FDA Safety Communication 
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1/4/2017 Postmarket Management of Cybersecurity in Medical Devices 
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11/15/2016 Practice Hospital Bed Safety 
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9/16/2016 FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance 
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9/9/2016 Traumatic Brain Injury: FDA Research and Actions 
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9/2/2016 Antibacterial Soap? You Can Skip It - Use Plain Soap and Water 
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9/1/2016 Opioid Pain or Cough Medicines with Benzodiazepines - Drug Safety Communication 
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9/9/2015 Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment 
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1/28/2015 Preventing Tubing and Luer Misconnections: Tips for Health Care Providers 
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1/27/2015 Patient Lifts: Safety Guide 
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