Class 2 Device Recall Boston Scientific HTA Thermal endometrial ablation system

• Date Initiated by Firm: January 24, 2007
• Date Posted: March 31, 2007
• Recall Status: Terminated on December 12, 2007
• Recall Number: Z-0688-2007
• Recall Event ID: 37291
• PMA Number: P000040
• Product Classification: Thermal endometrial ablation system - Product Code MNB
• Product: HTA Console System, 230 Volt, English, Product Number: 560010 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
• Code Information: Unit Numbers: IN0335JC, IN0337JC, IN0341JD, IN0342JD, IN0343JD, IN0344JE, IN0345JE, IN0347JE, IN0348JE, IN0349JE, IN0352JG, IN0353JG, IN0355JG, IN0356JG
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; One Boston Scientific Place; Natick MA 01760-1536
• For Additional Information Contact: Cindy Finney; 508-683-4186
• Manufacturer Reason for Recall: Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment
• FDA Determined Cause: Other
• Action: Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.
• Quantity in Commerce: 14 units
• Distribution: Worldwide-USA, UK, Denmark, Italy, and France
• Total Product Life Cycle: TPLC Device Report

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.

• PMA Database: PMAs with Product Code = MNB