Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and

FDA device recall Z-1248-06 · posted 2006-07-19 · Terminated

Recall details

Recalling firm

Celsion Corporation

Reason for recall

A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may fail to achieve or maintain recommended pressure.

Action taken

Celsion Corporation, the recalling firm, notified consignees by letter 05/04/06 on Boston Scientific Corporation letterhead and advised that the prostatic balloon of the catheter may not achieve and/or maintain the recommended pressure as outlined in the Prolieve User Manual. The notification was sent by courier and included a tracking verification reply form for users to report inventory quantities and to report that all areas of medical facilities holding inventory were checked for recalled product for return via Returned Goods Authorization from contract distributor, Boston Scientific Corporation, Natick, MA.

Root cause

Other

Status

Terminated

Product code

MEQ

Quantity affected

2930 kits

Distribution

Nationwide. The product was distributed to one distributor in MA and 154 end users in medical centers and urology clinics.

Date initiated

2006-05-04

Date posted

2006-07-19

Date terminated

2011-08-04

Location

Columbia, MD