Class 2 Device Recall HydroThermAblator Endometrial Ablation System

• Date Initiated by Firm: July 31, 2009
• Date Posted: September 22, 2009
• Recall Status: Terminated on May 03, 2011
• Recall Number: Z-2208-2009
• Recall Event ID: 52780
• PMA Number: P000040
• Product Classification: Endometrial Thermal Ablation Device - Product Code MNB
• Product: Boston Scientific HydroThermAblator Endometrial Ablation System- HTA Procedure Set (5/bx) Material/UPN/Catalog Number: M006550161 Boston Scientific HydroThermAblator Endometrial Ablation System-HTA Procedure Set (ea) Material/UPN/Catalog Number: M006550160 Intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete.
• Code Information: Lot Numbers: 35773, 35854, 35855, 36070, 36071, 36072, 36073, 36259, 36462, 36463, 36852, 37046, 37047, 37432, and 37433.
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Same; 508-683-8000
• Manufacturer Reason for Recall: Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns.
• FDA Determined Cause: Process design
• Action: Boston Scientific issued an Urgent Medical Device Recall - Immediate Action Required notification to hospitals and distributors dated July 31, 2009 via Federal Express and requested the immediate discontinued use and segregation of Recall product for return and Complete and return the Reply Verification Tracking Form. An email was sent to Physicians to provide the recall information. Boston Scientific issued a Clarification letter dated August 6, 2009 via Federal Express as a follow-up to the July 31, 2009 Recall letter for the following reason: customers may remove product from the outer box and store it on the inventory shelf by the inner package only. If this is a practice at the facility, a customer must consider both the inner and outer packaging product codes when searching for affected recalled product as the UPN numbers on the inner and outer labeling are different. A reply verification tracking form for customers was provided in case they have located any additional product to return.
• Quantity in Commerce: 1,555 eaches
• Distribution: Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
• 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