Cordis Corporation CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation, Miami Lakes, FL 33014
Brand
Cordis Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Cordis Corporation is recalling CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corpora due to Slow Deflation or No Deflation. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Slow Deflation or No Deflation
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026