—#83804

Product

Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.

FDA product code: MEQ — System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P030006
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Nationwide distribution, including Puerto Rico.

Timeline

Recall initiated: 2009-07-20
Posted by FDA: 2009-07-28
Terminated: 2010-03-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #83804. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.