Sorin Stockert 3T Heating-Cooling Device Infections
The Sorin Stockert 3T Heater-Cooler is a medical device used during open-heart surgery to regulate the temperature of patients. It is manufactured and sold by Sorin Group USA, Sorin Group Deutschland GMBH and LivaNova PLC.
Sorin announced in June of 2014 that 15 patients had acquired non-tuberculosis mycobacteria infections (Mycobacterium abscessus/M. abscessus) following the use of the device during their surgeries. Four of the 15 patients died as a result of their infections. The manufacturers sent out a letter to around 180 patients during that time warning them that they may have been exposed to Mycobacterium abscessus during their surgeries.
In July 2015, the Food and Drug Administration (FDA) issued a recall for the Sorin 3T Heater-Cooler devices related to the infection risk that the device allegedly poses to patients. Following the recall, the FDA then released a safety communication in October of 2015 regarding several reports it had received indicating that the use of the Sorin 3T system was causing problems during surgery. The FDA says that it has received at least 32 reports of bacterial device contamination and patient infections linked to the Sorin 3T from January 2010 to August 2015.