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U.S. Department of Health and Human Services

Class 2 Device Recall HydroThermAblator Endometrial Ablation System

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 Class 2 Recall
HydroThermAblator Endometrial Ablation System
see related information
Date Posted September 22, 2009
Recall Status1 Open
Recall Number Z-2209-2009
Recall Event ID 52780
Product Classification Device, Thermal Ablation, Endometrial - Product Code MNB
Product Boston Scientific HydroThermAblator Endometrial Ablation System- HTA® System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (5/bx) Material/UPN/Catalog Number: M006560201 System-HTA® System Procedure Set with Tenaculum Stabilizer and Disposable Heater Canister (ea) Material/UPN/Catalog Number: M006560200 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: 35421, 35422, 35423, 35424, 35425, 35426, 35846, 35847, 35890, 35891, 35892, 36038, 36039, 36040, 36041, 36042, 36047, 36048, 36104, 36105, 36141, 36142, 36143, 36146, 36147, 36148, 36214, 36215, 36234,36235, 36249, 36250, 36251, 36260, 36261 ,36370, 36371, 36372, 36467, 36468, 36682, 36683, 36684, 36685, 36686, 36688, 36689, 36690, 36693, 36694, 36695, 37049, 37098, 37099, 37149, 37150, 37151, 37154, 37192, 37218, 37219, 37220, 37221, 37222, 3and 7223.
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, Massachusetts 01752-1234
Consumer Instructions Contact the recalling firm for information
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 2
DESIGN: 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 22,744 eaches
Distribution Worldwide Distribution -- USA, Austria, Denmark, Finland, France, Great Britain, Italy, Netherlands, and Sweden.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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