FDA Medical Device Recalls (openFDA)
Cordis Corporation: CORDIS "Fire Star" 2.50 x 20 Dilatation Catheter, Catalog # 80120250, Distributed by Cordis Corporation, Miami Lakes, FL 33014
- Recall number
- Z-0812-2008
- Recalling firm
- Cordis Corporation
- Product
- CORDIS "Fire Star" 2.50 x 20 Dilatation Catheter, Catalog # 80120250, 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
- 52 Ea
- Distribution
- Worldwide.
- Lot, serial or model codes
- Lot #s: 13187448 13191357 13197625 13197626 13203922 13203923 13212424 13212425 13224187 13224189 13225882 13231288 13232326 13233516 13236343 13237912 13242129 13246360 13247918 13252929 13253835 13270369 13279283 13280403 13281233 13281287 13281301 13281328 13281330 13281333 13281392 13281399 13281427 13282483 13283210 13285523 13288830 13290337 13292699 13294554 13297302 13302302 13306834 13311785 13313289 13314187 13315462 13316298 13317745 13321822 13325807 13325808
- 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