FDA issues Safety Alert for frameless stereotaxic navigation systems
Editor's Note The Food and Drug Administration (FDA) on June 15 issued a Safety Alert for frameless stereotaxic navigation systems because of navigational accuracy errors during surgical procedures. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged surgical procedures. The FDA…
FDA releases list of reusable devices requiring new validated IFU, validation data
Editor's Note The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017. The list includes: Bronchoscopes (flexible or…
FDA extends UDI compliance dates for Class I, unclassified devices
Editor's Note The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020,…
FDA: Class I recall of Zimmer Biomet implantable spinal fusion stimulators
Editor's Note The Food and Drug Administration (FDA) on May 30 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its SpF PLUS-Mini and SpF XL IIB implantable spinal fusion stimulators as Class I, the most serious. The recall was initiated because of higher than allowed levels of potential harmful…
FDA: Class I recall of HeartMate II LVAS Pocket System Controller
Editor's Note The Food and Drug Administration (FDA) on May 23 identified the recall by Abbott-Thoratec (Pleasanton, California) of its HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller as Class I, the most serious. Abbott-Thoratec has receives 70 reports of incidents in which the controller malfunctions after an exchange,…
FDA: Class I recall of Wingman35 Crossing Catheters
Editor's Note The Food and Drug Administration on May 17 identified the recall by ReFlow Medical (San Clemente, California) of certain lots of its Wingman35 Crossing Catheters as Class I, the most serious. The catheters are being recalled because of tip splitting or separation that has resulted in two adverse…
FDA: Abbott recalls coronary catheters
Editor's Note The Food and Drug Administration on May 16 announced the recall by Abbott of specific lots of three coronary dilation and balloon catheters: NC Trek RX Coronary Dilation Catheter NC Traveler Coronary Dilation Catheter NC Tenku RX PTCA Balloon Catheter. The affected lots were manufactured between January 2015…
FDA: HeartWare VAD splice kit recalled
Editor's Note The Food and Drug Administration (FDA) on May 5 announced that Medtronic is recalling its splice kit used to repair the driveline of the HeartWare Ventricular Assist Device (VAD). The kit was recalled because of a design problem that prevents the repaired cable assembly from withstanding excessive force…
FDA: Safety alert for Medtronic’s NavLock Tracker
Editor's Note The Food and Drug Administration (FDA) on May 3 issued a Safety Alert for Medtronic’s NavLock Tracker. Medtronic has received 196 medical device reports that included two patient deaths after procedures in which non-Medtronic instruments were used with the NavLock Tracker. The NavLock Tracker enables navigation of Medtronic…
FDA: Class I recall of Medtronic HVAD controllers, DC adapters
Editor's Note The Food and Drug Administration (FDA) on April 18 designated the recall by Medtronic of its HVAD (HeartWare [left] ventricular assist device) system controllers and DC adapters as Class I, the most serious. Medtronic is issuing an updated controller and has begun to remove current HVAD controllers. The…
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