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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm July 28, 2005
Date Posted July 19, 2005
Recall Status1 Terminated 3 on June 14, 2006
Recall Number Z-1020-05
Recall Event ID 32601
PMA Number P000040 
Product Classification Device, Thermal Ablation, Endometrial - Product Code MNB
Product Adapter for ACMI Hysteroscope
Catalog Number: 55035
Code Information Lot Number: 20410191
Recalling Firm/
Manufacturer		 Boston Scientific Marlbourgh
100 Fairbanks Blvd
Marlborough MA 01752-1234
For Additional Information Contact Robert T. Miragliuolo
508-683-4186
Manufacturer Reason
for Recall		 The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.
FDA Determined
Cause 2		 Other
Action Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions
Distribution CA, DE, FL, MA, MO, MS, OH, NE, NY, PA, UT, WI
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.
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