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…
FDA: Field corrective action for Medtronic’s Newport HT70, HT70 Plus ventilators
Editor's Note On April 5, the Food and Drug Administration (FDA) announced that Medtronic (Minneapolis) has notified its customers of a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The field corrective action is being conducted after reports that the ventilator may reset…
Olympus redesigned duodenoscope linked to new infection outbreak
Editor's Note A new outbreak of infections outside the US have been tied to a duodenoscope Olympus modified last year to reduce the risk of transmitting bacteria between patients, the March 22 Los Angeles Times reports. The outbreak of Klebsiella pneumoniae in five patients occurred at the end of December…
FDA: Class I recall of HeartStart MRx Monitoy/Defibrillator
Editor's Note The Food and Drug Administration (FDA) on March 24 identified the recall of the HeartStart MRx Monitor/Defibrillator by Phillips Healthcare (Amsterdam) as Class I, the most serious. The recall was initiated because of electrical and battery connection issues that may prevent the device from powering up, charging, and…
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