International Medical Devices Database

Manufacturer Address
Celsion Corporation, 10220 Old Columbia Road, Suite L, Columbia MD 21046-2364
Source
USFDA
1 Event
- Recall of Device Recall Prolieve

One device in the database

Device Recall Prolieve

Model / Serial
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
Product Classification
Gastroenterology-Urology Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide. The product was distributed to one distributor in MA and 154 end users in medical centers and urology clinics.
Product Description
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***.

2 manufacturers with a similar name

Learn more about the data here

Celsion Corporation

Manufacturer Address
Celsion Corporation, 10220 Old Columbia Rd Ste L, Columbia MD 21046-2364
Source
USFDA

Celsion Corporation, Inc.

Manufacturer Address
Celsion Corporation, Inc., 10220 Old Columbia Road, Suite L, Columbia MD 21046-2364
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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