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U.S. Department of Health and Human Services

Class 2 Device Recall Prolieve

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  Class 2 Device Recall Prolieve see related information
Date Initiated by Firm May 04, 2006
Date Posted July 19, 2006
Recall Status1 Terminated 3 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 
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 2		 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 and Original Applicant = MEDIFOCUS, INC
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