BEUDAMED
    FDA Recall Terminated

    Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046***

    Recall: Z-1339-04 · Initiated July 19, 2004

    Recall

    Recall Number
    Z-1339-04
    Event Number
    29633
    Firm
    Celsion Corporation
    FEI Number
    1122126
    Product Code
    MEQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 19, 2004
    Posted
    August 11, 2004
    Terminated
    March 31, 2005
    Address
    10220 Old Columbia Rd, Ste L, Columbia, MD, 21046-2364

    Description

    Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046***

    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.

    Distribution

    Devices were distributed to 19 medical facilities and physician end users nationwide by the recalling firm''s contract distributor.

    Quantity

    28 devices