FDA 483 - LivaNova Deutschland GmbH - April 28, 2022

LivaNova Deutschland GmbH, a medical device manufacturer in Munich, Germany, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish design validation procedures for its Heater-Cooler System 3T, including insufficient testing of updated Instructions for Use following recalls. Additionally, the disinfection process for the device was not adequately validated, and complaints involving device failures were not investigated as required.