FDA 483 - Maquet Cardiovascular, LLC - February 26, 2021

Maquet Cardiovascular, LLC received a Form 483 citing significant deficiencies across its quality system, particularly in corrective and preventive actions, complaint handling, and medical device reporting. The firm repeatedly failed to address recurring issues, properly investigate device failures, and submit timely or accurate MDRs, indicating a systemic breakdown in quality management. Design validation and risk analysis procedures were also found to be inadequate, with critical documentation not updated or followed.