FDA 483 - Thoratec LLC - May 30, 2025

An FDA inspection of Thoratec LLC, conducted between April 7 and May 30, 2025, identified two significant observations concerning the firm's quality system. The first observation noted inadequate procedures for design change, specifically regarding software validation for updates to their HeartMate Touch device. Validation testing for new software versions (b)(4) and (b)(4) lacked robust evaluation under fault, stress, or actual use conditions, which is crucial for ensuring device reliability. The second observation highlighted deficiencies in the documentation of corrective and preventive action (CAPA) activities. A specific CAPA (137767), related to the HeartMate 3 LVAS Kit and Controller, failed to thoroughly investigate all potential issues discovered during an inquiry into a UI Membrane lift. These observations indicate non-compliance with quality system requirements under the Federal Food, Drug, and Cosmetic Act. While the firm has committed to correcting these issues, Thoratec LLC is ultimately responsible for conducting comprehensive internal audits to identify and rectify all violations to maintain regulatory compliance and product quality.