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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Thermal endometrial ablation system

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 Class 2 Device Recall Boston Scientific Thermal endometrial ablation systemsee related information
Date Initiated by FirmJanuary 24, 2007
Date PostedMarch 31, 2007
Recall Status1 Terminated 3 on December 12, 2007
Recall NumberZ-0687-2007
Recall Event ID 37291
PMA NumberP000040 
Product Classification Thermal endometrial ablation system - Product Code MNB
ProductHTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)
Code Information Unit Numbers: N1190JC, N1191JC, N1192JC, N1194JC, N1197JC, N1199JC, N1200JC, N1201JC, N1203JC, N1204JC, N1205JC, N1206JC, N1208JC, N1210JC, N1211JC, N1214JC, N1215JC, N1217JC, N1218JC, N1220JC, N1222JC, N1226JC, N1227JC, N1229JC, N1230JC, N1231JC, N1232JC, N1233JC, N1234JC, N1235JC, N1237JC, N1238JK, N1239JF, N1240JF, N1241JF, N1242JF, N1243JF, N1245JF, N1247JF, N1251JF, N1252JF, N1253JF, N1254JF, N1255JF, N1257JF, N1258JF, N1259JF, N1261JF, N1262JF, N1263JF, N1264JF, N1266JF, N1267JF, N1268JF, N1269JF, N1294JI, N1295JI,
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760-1536
For Additional Information ContactCindy Finney
508-683-4186
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		Other
ActionBoston 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 Commerce57 units
DistributionWorldwide-USA, UK, Denmark, Italy, and France
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = MNB
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