Category: Medical Devices
Federal Judge Reviewing Five Essure Lawsuits
January 18, 2016 — A federal judge in Philadelphia is set to decide whether to allow five lawsuits involving Bayer's Essure sterilization device to move forward. Philly.com reports that U.S. District Judge John R. Padova asked attorneys representing the women...
Olympus Duodenoscope Recalled to Reduce Risk of Infection
January 15, 2015 — Olympus Corp. will recall a duodenoscope to make repairs intended to reduce the risk of bacterial infections. The Olympus TJF-Q180V scope has been on the market since 2010 without clearance from the FDA or proof the...
Reporting Delays Led to Hundreds of Scope Infections
January 14, 2016 — Olympus Corp. knew their duodenoscopes could transmit infections in 2012 but did not warn doctors or the FDA for nearly three years, according to a Senate Health Committee report (PDF). Olympus manufactures 85% of the duodenoscopes...
FDA Warns Against Using Customed Surgical Packs and Trays
January 12, 2016 — The FDA is warning healthcare providers not to use surgical convenience packs and trays made by Customed Inc. because they may not be sterile. According to the Safety Communication, this is the third Class I recall...
FDA Recalls Chest Drainage Catheter Because It Can Break
Our law firm is filing lawsuits for people who were injured by a defective heart catheter, such as the Fuhrman Pleural and Pneumopericardial Drainage Set.
Rep. Demands Answers from FDA on Morcellator Deaths
U.S. Representative Michael G. Fitzpatrick has sent a letter asking the FDA to open a criminal investigation into why three hospitals failed to report deaths related to the use of morcellators during hysterectomies and fibroid surgery.
Texas Chariot Device Class Action Lawyer
The Chariot™ Guiding Sheath has been recalled after reports of the shaft breaking inside patients as it was being pulled out. The FDA warns that broken pieces can travel in the bloodstream and cause deadly complications. Emergency surgery may also...
Texas Chariot Guiding Sheath Lawyer
A voluntary recall has been issued for the Chariot™ Guiding Sheath after more than a dozen reports of shaft separation. Several patients needed additional medical procedures to retrieve pieces that broke off inside their body during surgery. Need a Texas...
Fujifilm Updates Cleaning Instructions for Duodenoscope
January 4, 2016 — The FDA has approved new instructions for cleaning the Fujifilm ED-530XT duodenoscope to reduce the risk of infection. In February 2015, the FDA announced that they were working with duodenoscope manufacturers to validate cleaning instructions to...