Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1339-04 · Posted 2004-08-11

Recalling FirmCelsion Corporation
Recall StatusTerminated
Product CodeMEQ
Date Initiated2004-07-19
Date Terminated2005-03-31
Product Quantity28 devices

Reason for Recall

Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑