FDA Medical Device Recalls (openFDA)
Cordis Corporation: CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D, Distributed by Cordis Corporation, Miami Lakes, FL 33014
- Recall number
- Z-0809-2008
- Recalling firm
- Cordis Corporation
- Product
- CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D, Distributed by Cordis Corporation, Miami Lakes, FL 33014
- Status
- Terminated
- Initiated
- 2008-01-14
- Posted
- 2008-02-06
- Terminated
- 2009-10-20
- Reason
- Slow Deflation or No Deflation
- Root cause
- Process control
- Action
- Cordis initated the recall on 1/14/2008. For U.S. customers: An Urgent Medical Device Recall letter and an Acknowledgement Form was sent to the following 4 individuals in each account: Cath Lab Director, Operating Room Director, Materials Director, Risk Manager; to be followed up with direct Cordis representative contact to facilitate obtaining signature, faxing form, collecting and returning units. For non-US customers, email notification with return acknowledgement is used to notify the affiliate distributors, who then notify and reconcile the customers in those countries. All users were instructed to immediately set aside product and return it for replacement.
- Quantity
- 133,300 units total for recalls Z-0747-0824-2008
- Distribution
- Worldwide.
- Lot, serial or model codes
- Lot #s: 13187447 13191356 13197623 13197624 13200866 13200867 13206136 13206138 13212422 13212423 13218318 13223383 13225879 13225880 13225881 13227558 13233514 13236342 13237910 13244058 13244489 13246359 13246860 13247917 13251136 13252924 13254620 13281299 13281397 13281453 13282066 13282067 13284574 13288058 13289756 13296516 13296517 13318532 13321817 and 13325804
- 510(k) numbers
- not on file
- PMA numbers
- ["P880003"]
- Product code
- LOX
- Firm FEI
- 1016427
- Firm city
- Miami Lakes
- Firm state
- FL
- 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