Class 2 Device Recall Prolieve

• Date Initiated by Firm: May 04, 2006
• Date Posted: July 19, 2006
• Recall Status: Terminated on August 04, 2011
• Recall Number: Z-1248-06
• Recall Event ID: 35573
• PMA Number: P030006
• Product Classification: microwave therapy for BPH - Product Code MEQ
• Product: Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.
• Code Information: 581451, 581452, 581464, 581465, 581468, 581471, 581472, 581473, 581474, 581475, 581476, 581477, 581478, 581479, 581480, 600145, 600146, 600147, 600408, 600538, 600540, 600630, 600692, 600771, 600814, 600815, 600874, 600875
• FEI Number: 1122126
• Recalling Firm/ Manufacturer: Celsion Corporation; 10220 Old Columbia Road; Suite L; Columbia MD 21046-2364
• For Additional Information Contact: Cindy Finney ; 800-862-1284
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 2930 kits
• Distribution: Nationwide. The product was distributed to one distributor in MA and 154 end users in medical centers and urology clinics.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• PMA Database: PMAs with Product Code = MEQ