Boston Scientific Corporation One Boston HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Brand
Boston Scientific Corporation One Boston
Lot Codes / Batch Numbers
Unit Numbers: IN0339JC, IN0340JC
Products Sold
Unit Numbers: IN0339JC, IN0340JC,
Boston Scientific Corporation One Boston is recalling HTA Console System, 230 Volt , Italian, Product Number: 56001 IO (HTA system is a software-contro due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Boston Scientific notiifed accounts by letter dated January 24, 2007 via federal Express Mail. Accounts were requested to examine inventory, remove and return product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026