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Class I Recall for Cranial Image-Guided Surgery System

The FDA issued a Class I recall for the Brainlab Crainial image-guided surgery system. A Class I recall is the most serious kind issued by the FDA, requiring a manufacturer to take immediate and urgent action to remove affected products from the market. The recall came after problems were reported regarding the navigation display on […]

Olympus Issues Recall for Unsafe Duodenoscope Devices

Olympus Corporation has issued a voluntary recall for the TJF-Q180V duodenoscope device. Duodenoscopes are used in more than 500,000 gastrointestinal endoscopic procedures each year. These devices are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures to diagnose and treat conditions within the bile duct and main pancreatic duct, such as gallstones and cancer. The duodenoscope can […]

Multidistrict Litigation Established for Bair Hugger Lawsuits

On December 11th, 2015, the United States Judicial Panel on Multidistrict Litigation issued an order to transfer fourteen lawsuits—related to the Bair Hugger Forced Air Warming device—to the U.S. District Court, District of Minnesota. This multidistrict litigation court (MDL) has been established to preside over all federally filed cases concerning claims that the Bair Hugger […]

Xarelto Bellwether Trials to Begin in 2017

Dates have been selected for the first Xarelto multidistrict litigation hearings. Pretrial discovery and bellwether trial selection for the Xarelto multidistrict litigation (MDL) has begun. The first trials will consist of a selection of four cases, from a pool of forty, that have been considered to represent the majority of the cases filed around the […]