FDA Medical Device Recalls (openFDA)
Cordis Corporation: CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, Distributed by Cordis Corporation, Miami Lakes, FL 33014
- Recall number
- Z-0799-2008
- Recalling firm
- Cordis Corporation
- Product
- CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, 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: 13187444 13191354 13191804 13191806 13197619 13199595 13211692 13214551 13218320 13221410 13221411 13224181 13224183 13227940 13229366 13230718 13237908 13242132 13244057 13246357 13247914 13251133 13255710 13262746 13268852 13281396 13281411 13282063 13283824 13283830 13283831 13284569 13285521 13288833 13289751 13291895 13295105 13297306 13301370 13304557 13309111 13313286 13316796 13321809 and 13323516
- 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