March 3, 2017 — LivaNova has recalled FlexTherm Heater Cooler Systems after conducting a “thorough review” of the product’s design and concluding that it “does not fully meet user requirements.”
LivaNova issued a Field Safety Notice (PDF) on February 6 to announce the device will be discontinued and voluntarily removed, but also said they can still be used until the hospital finds a replacement.
LivaNova (Sorin Group Deutschland) manufactures three types of heater-cooler units:
- FlexTherm Heater Cooler System
- SIII Heart Lung Machine Modular System: Heater Cooler
- Stockert 3T Heater Cooler System
FlexTherm was approved by the FDA in January 2014 with a 510(k) application, which means it did not go through clinical trials because it was “equivalent” to the Stockert 3T Heater Cooler System. The biggest difference between the FlexTherm and the 3T is a new user interface and materials, but otherwise they are nearly identical.
The problem with the 3T is a vent in the back of the machine that sprays water — and potentially deadly bacteria — into the air of an operating room. If bacteria lands inside a patient’s open chest, it can cause an infection, but symptoms may not appear for up to 6 years.
Last year, health officials issued a number of warnings about Mycobacterium chimaera infections in patients who had open-heart surgery in an operating room where LivaNova’s 3T heater-cooler was used.
The FDA also said evidence “strongly suggests” a single source of contamination — likely LivaNova’s manufacturing facility in Germany. In January 2017, a study found M. chimaera in 80% of heater-cooler units, suggesting “mycobacterial contamination might be a general problem for HCUs.”
Do I have a Heater Cooler Infection Lawsuit?
The Schmidt Firm, PLLC is currently accepting heater-cooler induced injury cases in all 50 states. If you or somebody you know had an infection after open-heart surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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