FDA Medical Device Recalls (openFDA)
Cordis Corporation: CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, Distributed by Cordis Corporation, Miami Lakes, FL 33014
- Recall number
- Z-0752-2008
- Recalling firm
- Cordis Corporation
- Product
- CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, 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: 13175334 13180559 13183022 13189427 13190063 13207208 13208068 13209914 13237270 13245567 13256453 13258616 13260158 13262741 13267862 13271048 13272941 13272942 13275165 13278670 13279267 13288829 13292688 13297292 13301346 13303778 13305481 13310832 13314810 and 13315454
- 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