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U.S. Department of Health and Human Services

Class 2 Device Recall 1500T12 Cool Path Ablation System Generator

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  Class 2 Device Recall 1500T12 Cool Path Ablation System Generator see related information
Date Initiated by Firm May 09, 2011
Date Posted June 23, 2011
Recall Status1 Terminated 3 on April 03, 2012
Recall Number Z-2630-2011
Recall Event ID 58859
Product 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.
Code Information Serial Number:  13620760, 13620761, 13639542
Recalling Firm/
Manufacturer		 St Jude Medical
One St Jude Medical Dr
Saint Paul MN 55117
Manufacturer Reason
for Recall		 The recall was initiated because St. Jude Medical has confirmed its T14 and T12 RF Generator may malfunction upon encountering an unexpected electric current (e.g. static electricity). The resulting malfunction results in a failure of the generator to respond to key presses properly, and may cause unexpected energy delivery or inability to discontinue energy delivery with the start / stop butt
FDA Determined
Cause 2		 Other
Action The firm, St. Jude Medical (SJM), sent a "Product Correction" letter dated May 9, 2011 to it's affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the T14/T12 generators and remote controls until the units have been properly serviced; complete and return the attached field action form, and utilize the units in accordance with the Operators Manual. In case of system malfunction, the customers were instructed to shut off the RF power delivery by turning off the generator via the rocker switch, dislodging the power cord, or disconnecting of the patient cable or indifferent electrode connection. An SJM sales representative will contact the customers in the near future to facilitate repair or exchange of the impacted unit. If you have questions regarding this notice, contact the Marketing Manager, AF at (905-286-4015), Marketing Director, AF/CRM, at (905-286-4107); Product Manager (Tokyo) 03-6255-5740, and/or your SJM sales representative.
Quantity in Commerce 154
Distribution International distribution only: Canada and Japan.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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