Cordis Corporation CORDIS "Fire Star" 3.00 x 20 Dilatation Catheter, Catalog # 80120300, 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 20 Dilatation Catheter, Catalog # 80120300, 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: 13187449 13191017 13197627 13200868 13212426 13212427 13218323 13224191 13226740 13230694 13231290 13233901 13239280 13246361 13247919 13252930 13281217 13281229 13281239 13281288 13281300 13281345 13281429 13281441 13281458 13282485 13283825 13286193 13290338 13294211 13294557 13294558 13301371 13303085 13304561 13311788 13311789 13311798 13312722 13314188 13321832 and 13325101
Cordis Corporation is recalling CORDIS "Fire Star" 3.00 x 20 Dilatation Catheter, Catalog # 80120300, 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