Cordis Corporation CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, 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" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, 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: 13211699 13228631 13239274 13255242 13278332 13279594 13281187 13281293 13281407 13282049 13293674 13294164 13294165 13301364 13303083 13305499 13319354 and 13321701
Cordis Corporation is recalling CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, 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