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U.S. Department of Health and Human Services

Class 2 Device Recall Prolieve Thermodilatation System ; Prolieve Thermodilatation System Kit with Disposable RTM

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 Class 2 Recall
Prolieve Thermodilatation System ; Prolieve Thermodilatation System Kit with Disposable RTM
see related information
Date Posted July 28, 2009
Recall Status1 Terminated on March 04, 2010
Recall Number Z-1692-2009
Recall Event ID 52715
Premarket Approval
PMA Number
P030006
Product Classification System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy - Product Code MEQ
Product Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.
Code Information Material Number M0068808022 with Lot/Batch Numbers: 604951, 604952, 604953, 604954, 604955, 604956, 604957, 604958, 604959, 604960, 605015, 605016, 605017, 605276, 605277, 605278, 605279, 605280, 605281, 605282, 605283, 605284, 605285, 605286, 605287, 605288, 605289, 605290, 605291, 605292, 605293, 605294, 605295, 605296, 605297, 605298, 605299, 605783, 605784, 605785, 605786, 605787, 605788, 605789, 605790, 605791, 606044, 606045, 606046, 606079, 606080, 606081, 606082, 606083, 606084, 606152, 606182, 606183, 606203, 606299, 606300, 606301, 606302, 606303, 606304, 606420, 606421, 606422, 606423, 606424, 606597, 606598, 606599, 606600, 606601, 606602, 606603, 606604, 606605, 606606, 606607, 606781, 606782, 606829, 606830, 606831, 606832, 606833, 606834, 606879, 606880, 607014, 607015, 607016, 607017, 607018, 607019, 607020, 607021, 607022, 607023, 607024, 607025, 607189, 607190, 607191, 607192, 607193, 607194, 607315, 607316, 607317, 607318, 607321, 607322, 607323, 607324, 607325, 607520, 607521, 607522, 607523, 607524, 607525, 607526, 607527, 607528, 607646, 607735, 607736, 607737, 607738, 607739, 607740, 608160, 608161, 608162, 608163, 608164, 608165, 608166, 608167, 608168, 608169, 608575, 608591, 608592, 608593, 608594, 608595, 608596, 608597, 608602, 608680, 608681, 619219, 619221, 619222, 619311, 619312, 619313, 623435, 623436, 627518, 627519, 628502, 628503, 628504, 633348, 633349, 633350, 637211, 637212, 637216, 637217, 637220, 639295, 639296, 642203, 642204, 642549, 642576, 644535, 644536, 644537, 647635, 647636, 650229, 650230, 650232, 650233, 650234, 651870, 651871, 651872, 653449, and M19406. Material Number M0068808170 with Lot/Batch Numbers: 608608, 608609, 608610, 608611, 608612, 651734, 651874, and 651877.
Recalling Firm/
Manufacturer
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, Massachusetts 01752-1234
Manufacturer Reason
for Recall
Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field.
FDA Determined
Cause 2
DESIGN: Process Design
Action Boston Scientific sent Customer notification letters via Federal Express Priority mail on July 20, 2009. A total of 812 US consignees were notified and a total of 26 consignees in Puerto Rico. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in their inventory. Follow-up communications will be made to the accounts that do not respond to this inquiry.
Quantity in Commerce 26,935 kits
Distribution Nationwide distribution, including Puerto Rico.
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.
PMA Database PMAs with Product Code = MEQ and Applicant = BOSTON SCIENTIFIC CORP.
PMAs with Product Code = MEQ and Applicant = CELSION CORP.
PMAs with Product Code = MEQ and Applicant = MEDIFOCUS, INC
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