Celsion Corporation, Inc. Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, 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, Material Number M0068808023, labeled in part *** Distributed by Boston Scientific Corporation, Natck, MA***Manufacturer: Celsion Corporation, Columbia, MD***.
Brand
Celsion Corporation, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot 600783 Exp Feb-08 Lot 600815 Exp Jan-08 Lot 600874 Exp Feb-08 Lot 600875 Exp Jan-08 Lot 600814 Exp Jan-08 Lot 600771 Exp Jan-08 Lot 600692 Exp Dec-07 Lot 600540 Exp Nov-07 Lot 600630 Exp Dec-07 Lot 600538 Exp Dec-07 Lot 600408 Exp Dec-07 Lot 600145 Exp Sep-07 Lot 600146 Exp Sep-07 Lot 600147 Exp Sep-07
Celsion Corporation, Inc. is recalling Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exc due to Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Surgical treatment kits containing medical device components were mislabeled with extended expiration dates.
Recommended Action
Per FDA guidance
The recalling firm notified the contract distributor on 2/17/06 to cease shipments. The distributor subsequently notified accounts on 3/22/06 with lot and shipment specific recall letters. The letters advised that consignees discontinue use of the affected lots for return to the distributor. Consignees were requested to return the reply verification form enclosed.
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 noticeDistribution
As reported by FDA
CO, FL, IL, IN, MA, MI, NJ, NY, OH
Page updated: Jan 10, 2026