Events

Recall of Device Recall Prolieve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Celsion Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35573
  • Event Risk Class
    Class 2
  • Event Number
    Z-1248-06
  • Event Initiated Date
    2006-05-04
  • Event Date Posted
    2006-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46409
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    microwave therapy for BPH - Product Code MEQ
  • Reason
    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.
  • 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.

Device

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***.
  • Manufacturer
    Celsion Corporation

Manufacturer

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