Radio Frequency Ablation  Devices
Audience: Thoracic Surgeons, hospital  administrators, other healthcare professionals

[Posted 12/12/2007]  FDA alerted healthcare professionals of reports of patient deaths associated  with the use of radio frequency (RF) ablation devices during lung tumor  ablation. Patient selection, subsequent treatment, and technical use of the RF  device, including placement and operation, may have contributed to the  fatalities. While RF ablation devices have been cleared for general  indications- ablation of soft tissue by thermal coagulation necrosis- the  devices have not been cleared specifically for lung tumor ablation. Healthcare  professionals should use caution when operating RF ablation devices, adhering  strictly to information contained in the labeled operating instructions,  Operators Manual, the Manufacturer's Instructions for Use and any training  provided. Additionally, if healthcare professionals plan to use RF ablation  devices to treat patients with lung tumors, they should consider enrolling  patients in an approved clinical study, where training is available.  

[December 11, 2007 - Public Health  Notification - FDA]

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Unretrieved Device Fragments
Audience: Radiologists, surgeons, hospital risk managers, other healthcare professionals