Z-0804-2008

CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation...

Name: Z-0804-2008 CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation...
Creator: Cordis Corporation
Published: 2008-01-14
License: https://open.fda.gov/license/

Cordis US Corp. / initiated 2008-01-14 / Terminated / root cause: manufacturing process

FDA source

Cordis Corporation began a recall of CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 on 2008-01-14. The reason FDA records is "Slow Deflation or No Deflation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0804-2008
Status: Terminated
Initiated: 2008-01-14
Posted: 2008-02-06
Terminated: 2009-10-20
Recalling firm: Cordis US Corp.
Product: CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation, Miami Lakes, FL 33014
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: Slow Deflation or No Deflation
Root cause tag: manufacturing process
FDA 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 in commerce: 133,300 units total for recalls Z-0747-0824-2008
Distribution: Worldwide.
Product codes and lots: Lot #s: 13187446 13191355 13197622 13200865 13214556 13221415 13223385 13225878 13231289 13236340 13239277 13247916 13261565 13264549 13268859 13279605 13280401 13280405 13281186 13281219 13281279 13281314 13281364 13281432 13281451 13282065 13284571 13287298 13292703 13293584 13295107 13304559 13306306 13309113 13314818 13315461 13317743 and 13321813

Product code LOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)