Boston Scientific Corporation Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Boston Scientific Corporation is recalling Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Be due to Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression ba. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026