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

FDA device recall Z-1692-2009 · posted 2009-07-28 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

MEQ

Quantity affected

26,935 kits

Distribution

Nationwide distribution, including Puerto Rico.

Date initiated

2009-07-20

Date posted

2009-07-28

Date terminated

2010-03-04

Location

Marlborough, MA