Cordis Corporation CORDIS "Fire Star" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S, 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" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S, 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: 13205391 13214555 13225514 13231292 13232325 13236341 13239278 13281236 13281280 13281371 13281422 13281443 13281455 13286586 13294207 13294209 13294210 13306833 13307827 and 13325803
Cordis Corporation is recalling CORDIS "Fire Star" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S, Distribut 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