TY - JOUR AU1 - AB - NBSv42n14_NBS 6/27/12 7:00 AM Page 105 Biomedical Safety & Standards Concise, accurate news reports for medical device safety professionals BS&S FEATURE August 15, 2012 Volume 42 Riata Leads Off the Market, but Controversy Number 14 Continues IN THIS ISSUE Device Maker Says Story is Being Pushed By Its Rivals Recalls & Field Corrections—Class I At this year’s meeting of the Heart Rhythm Society, in May, it was standing Curlin Infusion room only, the crowd overflowing to surround monitors placed in hallways Administration Sets ......105 outside the meeting room, as prominent cardiologists presented what we know, now, regarding Riata and Riata ST implantable cardioverter defibrillator (ICD) Other-Sonic Generic Ultrasound Gel ........108 leads. Both leads were the subject of class I recalls by St. Jude Medical (SJM) in early 2012. Baxa Corp Abacus TPN Calculation Software ....108 There have been plenty of problems with ICD leads made by other manufac- Recalls & Field turers that went on to be recalled—Medtronic’s Sprint Fidelis, for example. But Corrections—Class II SJM ensured the Riata recalls would take on a life of their own when it went on the offensive against a journal, HeartRhythm, and a researcher, Robert G. Hauser, Monoject Safety MD, for publication TI - Other-Sonic Generic Ultrasound Transmission Gel JF - Biomedical Safety & Standards DO - 10.1097/01.BMSAS.0000417819.32721.22 DA - 2012-08-01 UR - https://www.deepdyve.com/lp/wolters-kluwer-health/other-sonic-generic-ultrasound-transmission-gel-n5WKJHc1Ly SP - 108 EP - 108 VL - 42 IS - 14 DP - DeepDyve ER -