Recall Z-0535-2007 ยท DYB Introducer, Catheter
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.
| Date | Mar 1, 2007 (initiated Oct 5, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The affected customers were notified on 10/5/06 by letter. |
| Quantity | 40 Units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER Daig Corp., May 14, 1997 |