Z-1692-2009

Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign...

Name: Z-1692-2009 Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign...
Creator: Boston Scientific Corporation
Published: 2009-07-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2009-07-20 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers... on 2009-07-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1692-2009
Status: Terminated
Initiated: 2009-07-20
Posted: 2009-07-28
Terminated: 2010-03-04
Recalling firm: Boston Scientific Corporation
Product: Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170.
Product code: MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
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.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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.

Product code MEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)