Device Recall 1500T12 Cool Path Ablation System Generator
Model / Serial
Serial Number: 13620760, 13620761, 13639542
Distribution
International distribution only: Canada and Japan.
Product Description
1500T12 Cool Path Ablation System - Generator || The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The generator has a maximum power output of 100 Watts. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode (dispersive pad or "DIP"), which is in compliance with ANSUAAMI Standard HF-18-60601-2-2. The Generator operates in Temperature Control mode only. The generator is a temperature controlled system, where temperature measured by the temperature sensor in the Therapy 1300 Series Steerable Ablation Catheter or other compatible catheters is monitored and the power delivered by the generator adjusts within the selected limits until the desired temperature is achieved. The generator's thermocouple temperature control circuitry is based on a Type T thermocouple. The front panel displays the actual real-time power output, impedance, duration, and measured tip electrode temperature. The amount and duration of RF power delivery is user selectable, The desired catheter tip electrode temperature is also user selectable. A low pass filter is enabled during ablation to permit recording of intracardiac electrograms and alternately disables the filter during stimulation (pacing). The output power of the Generator will shut off if the measured temperature exceeds 80¿C or if the measured temperature exceeds the user selected temperature set point by more than 5¿C for more than 3 seconds. The Generator has built-in safety features, which include a self test at power up and automatic RF power shut off if the measured tissue impedance falls below 50 Ohms or exceeds 300 Ohms or the preset impedance value for more than 2 seconds. The 1500Tl2 Cardiac Ablation Generator is only compatible with the Cool Point Irrigation Pump.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.