infected medical devices Legal News Articles & Interviews

Santa Clara, CA The chances of developing an infection after cardiac surgery is slim – an estimated 1 in 5,000 patients who had heart valve surgery and even lower for other types of surgery. But that percentage is higher if a Stockert 3T Heater-Cooler was used during surgery. Rod says he hasn’t recovered from his heart surgery and Carol’s husband died from infection. Now they are pursuing a claim against Sorin, the heater-cooler device manufacturer.   

Santa Clara, CA Since M. chimaera contamination was found during tests at Sorin’s manufacturing facility in 2014, and its 3T Heater-Cooler devices subsequently recalled, the FDA has kept close tabs on Sorin, now known as LivaNova.

Toronto, ON A class action lawsuit certified by an Ontario Superior Court judge accuses LivaNova (formerly Sorin), the manufacturer of Sorin 3T Heater-Cooler System, a medical device used to regulate the temperature of fluids during open heart surgeries, of failure to adequately warn hospitals of severe infection risk to open-heart surgery patients.

Philadelphia, PA: If a medical device isn’t recalled, chances are you won’t know it’s defective until research has been published, and then attorneys create an awareness. Sometimes the FDA sits on adverse event reports for years before warning the public. Case in point: the Stöckert 3T heater-cooler system. The FDA has been getting adverse event reports about the 3T since early 2010, but it only recently issued a public warning.