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…
FDA: Label changes for use of general anesthetic, sedation drugs in young children
Editor's Note The Food and Drug Administration (FDA) on April 27 issued a Safety Alert saying the agency had approved label changes on the use of general anesthetic and sedation drugs in children younger than 3 years. The changes include: A new warning that exposure to these drugs for lengthy…
FDA: Hospira recalls 25% Dextrose Injection
Editor's Note The Food and Drug Administration (FDA) on April 24 announced the recall by Hospira (Lake Forest, Illinois) of one lot of 25% Dextrose Injection, USP, (infant) prefilled syringes because of the presence of particulate matter identified as human hair. The affected lot is NDC: 0409-1775-10, Lot 58382EV, Expiry…
FDA: Recall of Isomeric sterile compounded products
Editor's Note The Food and Drug Administration (FDA) on April 6 announced the recall of all lots of sterile products compounded and packaged by Isomeric Pharmacy Solutions (Salt Lake City, Utah). The recall was issued because of FDA concerns of a lack of sterility assurance, which were brought to Isomeric’s…
FDA: Recall of Medtronic’s StrataMR adjustable valves and shunts
Editor's Note The Food and Drug Administration (FDA) on April 8 announced the recall of all StrataMR adjustable valves and shunts manufactured by Medtronic (Dublin, Ireland). The recall was issued because of a postimplantation problem that can lead to under-drainage of cerebrospinal fluid, which can lead to headaches, nausea, vomiting,…
FDA: Class I recall of Merit Medical’s sheath introducer
Editor's Note The Food and Drug Administration (FDA) on March 31 labeled Merit Medical Systems' (South Jordan, Utah) recall of the Prelude Short Sheath Introducer as Class I, the most serious. The recall was issued because of a manufacturing defect that may cause the tip to separate from the sheath…
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