FDA: Class I recall of Medtronic’s Extracorporeal Blood Pumping Console
Editor's Note The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass. The recall was initiated…
FDA issues Class I recall of certain Medtronic ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…
FDA: Class I recall of Medtronic’s Valiant Navion Thoracic Stent Graft System
Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…
FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface
Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…
FDA: Class I recall of ACIST Kodama Intravascular Ultrasound Catheter
Editor's Note The Food and Drug Administration (FDA), on March 17, identified the recall by ACIST of its Kodama Intravascular Ultrasound Catheter as Class I, the most serious. The recall was initiated because the O-ring housing tubing may squeeze and damage the O-ring. If there is damage, broken O-ring pieces…
FDA: Class I recall of Medtronic's HVAD Pump Implant Kits
Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…
FDA: Class I recall of Alaris Infusion Pump System and Modules
Editor's Note The Food and Drug Administration (FDA) on March 6 identified the recall by Becton Dickinson (BD)/CareFusion 303 of its Alaris System Infusion Pumps and Modules as Class I, the most serious. The recall was initiated because of multiple system errors, software errors, and use-related errors. The errors can…
FDA: Class I recall of King Systems’ video laryngoscope adapter
Editor's Note The Food & Drug Administration (FDA) on February 27 identified the recall by King Systems of its King Vision Video Laryngoscope Adapter (size ½) as Class I, the most serious. The recall was initiated because all devices from the affected lots show a reversed image on the display,…
FDA: Class I recall of Tytek Medical TM-317 PneumoDart-Pneumothorax Needle
Editor's Note The Food & Drug Administration on February 25 identified the recall of Tytek Medical’s TM-317 PneumoDart-Pneumothorax Needle as Class I, the most serious. The recall was initiated because of the risk of blockage in the needles caused by the presence of adhesive from the assembly process. The company…
FDA: Class I recall of Abbott coronary dilatation catheters
Editor's Note The Food & Drug Administration on February 19 identified the recall by Abbott Vascular of its NC Trek RX and NC Traveler RX Coronary Dilatation Catheters (diameter 4.0 mm, 4.5 mm, and 5.00 mm) as Class I, the most serious. The recall was initiated because of failure of…
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