Class 2 Device Recall 1500T14 Cardiac Ablation System Generator

• Date Initiated by Firm: May 09, 2011
• Date Posted: June 23, 2011
• Recall Status: Terminated on April 03, 2012
• Recall Number: Z-2631-2011
• Recall Event ID: 58859
• Product: 1500T14 Cardiac Ablation System - Generator The 1500Tl4 Cardiac Ablation System operates in conjunction with a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) electrode. The catheter delivers RF power in a monopolar mode between its distal electrode and the DIP electrode. The Generator incorporates a medical grade power supply. This power supply can be used for various line voltages and frequencies without any modifications. Utilizing microprocessor control, the Generator produces a continuous nonmodulated radio frequency (RF) output at 485 KHz. Its front panel displays the command power output, tissue impedance, and tissue temperature. The Generator measures root-mean-square (RMS) voltage, RMS current, and command power output by taking the average value of the product of voltage and current. This reflects the effective heating power delivered to the tissue from the catheter large electrode (tip electrode or other ablating electrodes). Impedance is calculated as RMS voltage divided by RMS current. The amount and duration of RF power delivery is user- selectable. The Generator has four (4) independent channels for monitoring the tissue temperature simultaneously using thermocouple sensor and i-channel (thermistor) for catheters using a thermistor sensor. The desired temperature is user-selectable when busing a catheter with a temperature sensor. If using a catheter with a temperature sensor, the output power of the Generator will shut off if the measured temperature exceeds 80C or if the measured temperature exceeds the user-selected temperature set point by more than 5C for greater than 3 seconds. If using a catheter with 4 temperature sensors, the output power of the Generator will shut off when the highest temperature detected from anyone of the temperature sensors is exceeds the preset temperature by more than 5C for greater than 3 seconds or exceeding 80C.The Generator has built-in safety features which include automatic RF power shutoff if the measured tissue impedance falls below 50 ohms or exceeds 300 ohms or the preset impedance value.
• Code Information: Serial Number 13637656, 13614863, 13614862.
• 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 but
• FDA Determined Cause: 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: 10
• 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.