Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
Brand
Edwards Lifesciences, Llc
Lot Codes / Batch Numbers
Lot Numbers: FR6F0111 (Exp 2008/06), FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08), FR6H0135 (Exp 2008/08), FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08)
Products Sold
Lot Numbers: FR6F0111 (Exp 2008/06), FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08), FR6H0135 (Exp 2008/08), FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08)
Edwards Lifesciences, Llc is recalling Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX0 due to Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised.
Recommended Action
Per FDA guidance
Consignees were notified by an Urgent Product Recall letter sent on 12/5/07. The letter instructed users to return any affected product to the recalling firm for replacement products. The letter also advised users that the likelihood of patient complications is extremely low for products that have already been implanted in patients. Users were requested to return a confirmation form after checking the inventory for any affected products. For additional information, contact 1-949-250-3779.
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