FDA Medical Device Recalls (openFDA)
Celsion Corporation: Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046***
- Recall number
- Z-1339-04
- Recalling firm
- Celsion Corporation
- Product
- Prolieve Thermodilatation System, model number M0068808000, labeled in part***Distributed by Boston Scientific Corporation, Natick, MA Manufactured by Celsion Corporation, Columbia, MD 21046***
- Status
- Terminated
- Initiated
- 2004-07-19
- Posted
- 2004-08-11
- Terminated
- 2005-03-31
- Reason
- Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
- Root cause
- Other
- 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.
- Quantity
- 28 devices
- Distribution
- Devices were distributed to 19 medical facilities and physician end users nationwide by the recalling firm''s contract distributor.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P030006"]
- Product code
- MEQ
- Firm FEI
- 1122126
- Firm city
- Columbia
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28