Cordis Corporation CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, 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: 13175334 13180559 13183022 13189427 13190063 13207208 13208068 13209914 13237270 13245567 13256453 13258616 13260158 13262741 13267862 13271048 13272941 13272942 13275165 13278670 13279267 13288829 13292688 13297292 13301346 13303778 13305481 13310832 13314810 and 13315454
Cordis Corporation is recalling CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, 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