Cordis Corporation CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, 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" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, 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: 13187445 13191016 13191800 13197620 13197621 13200143 13200144 13200145 13218321 13221412 13221413 13222784 13224943 13224944 13230719 13235886 13237909 13246358 13247915 13252066 13253834 13265037 13268858 13279599 13281193 13281201 13281202 13281224 13281267 13281302 13281318 13281390 13281431 13281450 13282064 13283832 13284570 13285522 13288834 13289754 13292702 13293582 13293583 13295106 13298196 13304558 13306300 13307100 13310118 13310119 13313287 13313288 13318531 13320190 13321811 and 13324440
Cordis Corporation is recalling CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, 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