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
    29633
  • Event Risk Class
    Class 2
  • Event Number
    Z-1339-04
  • Event Initiated Date
    2004-07-19
  • Event Date Posted
    2004-08-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34258
  • 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
    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy - Product Code MEQ
  • Reason
    Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
  • Action
    Celsion Corporation ceased distribution of the device 6/25/04 and implemented a field correction by company representatives at end user facilities on 6/25/04 consisting of computer clock reset. The firm subsequently notified end users on 7/19/04 by certified letter, which included a warning sticker to be placed on the device control screen. The notification and sticker instructed users not to use the device if there is a possibility of the computer clock transitioning through midnight during the procedure.

Device

Device Recall Prolieve
  • Model / Serial
    CEL0204AK CEL0204BK CEL0204CK CEL0204DK CEL0204EK CEL0204FK CEL0204GK CEL0204HK CEL0204IK CEL0204JK CEL0604AK CEL0604BK CEL0604CK CEL0604DK CEL0604EK CEL0604FK CEL0604GK CEL0604HK CEL0604IK CEL0604JK CEL0604KK CEL0604LK CEL0604MK CEL0604NK CEL0604OK CEL0604PK CEL1904AK CEL1904BK
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Devices were distributed to 19 medical facilities and physician end users nationwide by the recalling firm''s contract distributor.
  • Product Description
    Prolieve¿ Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046***
  • Manufacturer
    Celsion Corporation

Manufacturer

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