St. Jude Medical Daig Division FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
Brand
St. Jude Medical Daig Division
Lot Codes / Batch Numbers
Lot number 1239904
Products Sold
Lot number 1239904
St. Jude Medical Daig Division is recalling FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, due to Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
Recommended Action
Per FDA guidance
The affected customers were notified on 10/5/06 by letter.
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