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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific HTA Thermal endometrial ablation system

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  Class 2 Device Recall Boston Scientific HTA Thermal endometrial ablation system see related information
Date Initiated by Firm January 24, 2007
Date Posted March 31, 2007
Recall Status1 Terminated 3 on December 12, 2007
Recall Number Z-0691-2007
Recall Event ID 37291
PMA Number P000040 
Product Classification Thermal endometrial ablation system - Product Code MNB
Product HTA Console System, 230 Volt , Italian,
Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Code Information Unit Numbers: IN0339JC, IN0340JC,
Recalling Firm/
Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760-1536
For Additional Information Contact Cindy Finney
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 2
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 2 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 and Original Applicant = Minerva Surgical, Inc.