FDA alerts healthcare providers about EVAR graft endoleaks
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…
FDA: Class I recall of Spectranetics’ Bridge Occlusion Balloon Catheter
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…
FDA clears first duodenoscope with disposable end cap
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…
FDA updates Safety Alert for urogynecologic surgical mesh by Boston Scientific
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…
FDA: OriGen recalls two lots of dual lumen ECMO catheters
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…
FDA to staff new digital health unit
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…
FDA: Class I recall of Datascope/MAQUET intra-aortic balloon pumps
Editor's Note The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious. The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump.…
FDA: Genetech recalls three lots of Activase
Editor's Note The Food and Drug Administration (FDA) on September 7 announced the recall by Genetech (South San Francisco, California) of three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. The vials of water, manufactured by Hospira Inc (Lake Forest, Illinois), may be…
FDA: Recall of Hydromorphone HCL and Levophed Injection by Hospira
Editor's Note The Food and Drug Administration (FDA) on September 5 announced the recall by Hospira Inc (Lake Forest, Illinois) of one lot of Hydromorphone HCL injection, USP, CII 2 mg/mL and four lots of Levophed (norepinephrine bitartrate) injection because of a lack of sterility assurance resulting from a damaged…
FDA issues alert for alcohol pads, benzalkonium chloride antiseptic towelettes by Foshan Flying Medical Products
Editor's Note The Food and Drug Administration (FDA) on September 1 issued a Safety Alert notifying healthcare professionals and patients not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products Co Ltd (China) because of lack of sterility and other quality issues. Use of…
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