Cordis Corporation CORDIS "Fire Star" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, 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 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, 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: 13200863 13221408 13224938 13235880 13264547 13271983 13280404 13281196 13281257 13281376 13281426 13288054 13291130 13305475 13307824 13311784 13316297 and 13321689
Cordis Corporation is recalling CORDIS "Fire Star" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, Distributed 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