Z-1248-06

Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger...

Name: Z-1248-06 Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger...
Creator: Celsion Corporation
Published: 2006-05-04
License: https://open.fda.gov/license/

Celsion Corporation / initiated 2006-05-04 / Terminated

FDA source

Celsion Corporation began a recall of Prolieve Thermodilatation Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog #... on 2006-05-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1248-06
Status: Terminated
Initiated: 2006-05-04
Posted: 2006-07-19
Terminated: 2011-08-04
Recalling firm: Celsion Corporation
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***.
Product code: MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
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 root 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.
Product codes and lots: 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 code MEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)