Celsion Corporation 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***. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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***.
Brand
Celsion Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Celsion Corporation is recalling Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exc due to A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The cat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026