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Impella Generation 1 Purge Cassettes have an increased risk of purge leaks. Purge leaks can lead to low pump pressure and pump stops
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Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software
Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death
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Stent Recall: Boston Scientific Removes Certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems
Boston Scientific is removing certain stents and delivery systems due to issues with deployment and expansion.
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FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases
FDA Launches Framework for Accelerating Development of Individualized Therapies for Ultra-Rare Diseases
http://www.fda.gov/news-events/press-announcements/fda-launches-framework-accelerating-development-individualized-therapies-ultra-rare-diseases
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Insufflation Unit Recall: Olympus Removes High Flow Insufflation Units
Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.
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Early Alert: Trividia Health Issues Correction for TRUE METRIX Blood Glucose Monitoring Systems
Trividia recommends that device users who receive an E-5 error code and are experiencing symptoms of high glucose should seek medical care immediately
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Electronic Homecare Bed Correction: Medline Updates Use Instructions for Homecare Beds
Medline updates use instructions for Electronic Homecare Beds due to risk of electrical fires and entrapment.
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FDA Approves Labeling Changes to Menopausal Hormone Therapy Products
FDA Approves Labeling Changes to Menopausal Hormone Therapy Products
http://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
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FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer
http://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer
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Emergency Response Safety Kit Recall: Airlife Removes Certain Broselow Pediatric Emergency Rainbow Tapes and Broselow ALS Organizers
AirLife is removing Broselow Rainbow Tapes due to incorrectly printed medication dosing information.