Cordis Corporation CORDIS "Fire Star" 3.00 x 10 Dilatation Catheter, Catalog # 80110300, 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 10 Dilatation Catheter, Catalog # 80110300, 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: 13187443 13191353 13191803 13197618 13205388 13214550 13224936 13227004 13237905 13260784 13264548 13265028 13268849 13281188 13281275 13281292 13281403 13281433 13289749 13293580 13293673 13295104 13301356 13305496 13309110 13314816 and 13323195
Cordis Corporation is recalling CORDIS "Fire Star" 3.00 x 10 Dilatation Catheter, Catalog # 80110300, Distributed by Cordis Corporat 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