FDA 483 - Medtronic CryoCath LP - October 31, 2024

Medtronic CryoCath LP in Montreal received a Form FDA 483 following an inspection from October 28-31, 2024. The inspection revealed that finished medical devices, specifically the PulseSelect Pulsed Field Ablation Loop Catheter, were labeled as "Sterile" but had not undergone the sterilization process. The firm failed to properly identify these non-sterile devices, indicating a critical control deficiency in product acceptance and identification.