Stöckert 3t Heater Cooler Device Produced By Livanova Plc
London business wire livanova plc nasdaq livn together with its subsidiaries as livanova or the company a market leading medical technology company today announced the implementation of a device modification to its existing 3t heater cooler devices in western europe during the past fiscal quarter livanova successfully completed verification and validation processes which.
Stöckert 3t heater cooler device produced by livanova plc. The device is used to control the temperature of a patient s blood and organs during cardiovascular procedures. The device first came to market in 2006. Be aware of livanova s previous urgent medical device correction letters. The stöckert 3t heater cooler devices also known as the livanova 3t hcd have been available in the u s since 2006 according to the fda.
The livanova 3t heater cooler system provides 3 circuits for fast and efficient heating and cooling to meet your patient and cardioplegia temperature needs. The centers for disease control and prevention cdc estimates the risk to be less than 1 percent. Hcds have been linked to serious bacterial infections which may be fatal in some patients. Has a serial number starting with 16s.
Cleveland clinic will continue to monitor updates from the cdc and fda detailing the concerns on the stockert 3t heater cooler devices manufactured by livanova plc. The stöckert 3t heater cooler system also known as the sorin 3t heater cooler system is produced by livanova plc. If using a livanova heater cooler system 3t that is not the new version i e.