Editor's Note The Food and Drug Administration (FDA) on October 21 announced the recall by SCA Pharmaceuticals (Little Rock, Arkansas) of various lots of injectable products.  The recall was initiated because of the potential for the products to contain microbial contamination.  Many of the recalled products are used in anesthesia,…

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Editor's Note The Food and Drug Administration (FDA) on October 19 issued an updated Safety Alert for implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators by St Jude Medical. Because batteries for the devices may fail earlier than expected, St Jude has made available a new battery performance management tool,…

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  Editor's Note The Food and Drug Administration (FDA) on October 13 cleared the Senhance System (TransEnterix Surgical Inc, Morrisville, North Carolina), a new robotically-assisted surgical device. The design of the Senhance System allows surgeons to sit at a console unit that provides a 3-D high-definition view of the surgical…

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Editor's Note The Food & Drug Administration (FDA) on October 3 issued a Safety Alert saying the agency had received an adverse event report on a patient who was diagnosed with bilateral hemorrhagic occlusive retinal vasculitis after being administered injections of a compounded triamcinolone, moxifloxacin, vancomycin (TMV) formulation in each…

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Editor's Note The Food & Drug Administration (FDA) on September 28 sent letters to vascular and cardiothoracic surgeons, radiologists, and cardiologists, alerting them to an increase in Type III endoleaks associated with endovascular graft systems used in endovascular aneurysm repair (EVAR) for abdominal aortic and aorto-iliac aneurysms. The FDA’s letter…

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Editor's Note The Food and Drug Administration (FDA) on September 25 categorized the recall by Spectranetics (Colorado Springs, Colorado) of its Bridge Occlusion Balloon Catheter (model 590-001) as Class I, the most serious. The Bridge Occlusion Balloon Catheter is used to temporarily block the superior vena cava when emergency control…

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Editor's Note The Food and Drug Administration (FDA) on September 20 cleared the first duodenoscope with a disposable end cap, which will improve access for cleaning and reprocessing. The new features of the Pentax ED34-i10T duodenoscope include a single-use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved…

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Editor's Note The Food and Drug Administration (FDA) on September 19 updated its Safety Alert for urogynecologic surgical mesh manufactured by Boston Scientific. After an extensive review of data and testing, the FDA has determined that the change in supplier of the polypropylene used to manufacture the mesh currently on…

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Editor's Note The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1). The recall was initiated because the catheters have the potential…

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Editor's Note The Food and Drug Administration (FDA) is filling 13 positions in a new digital health unit that was created as part of the FDA Reauthorization Act of 2017, the September 11 FierceHealthcare reports. The FDA intends to build a group of experts who are experienced with software lifecycle…

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