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

• Date Initiated by Firm: July 20, 2009
• Date Posted: July 28, 2009
• Recall Status: Terminated on March 04, 2010
• Recall Number: Z-1692-2009
• Recall Event ID: 52715
• PMA Number: P030006
• Product Classification: Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH - 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.
• FEI Number: 3005099803
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: 508-683-8000
• 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: 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 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 = MEQ