Recall Z-1426-04 ยท DYB Introducer, Catheter
St. Jude Medical/Daig Division
Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is packaged in an open, semi-rigid plastic tray, which is then placed in a sterile barrier pouch consisting of Tyvek on one side and a clear plastic film on the other. This pouch is then heat sealed prior to sterilization.
| Date | Sep 1, 2004 (initiated Aug 4, 2004) |
| Status | Terminated |
| Reason | St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inventory at St. Jude Medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis. |
| Root cause | Other |
| Action | 100% of customers were notified by a personal visit by a St. Jude Medical representative, starting 8/4/2004. Letters were given by the representative to the consignee concerning the recall. |
| Quantity | 55 kits |
| Distribution | US, Canada, Belgium, Hong Kong, and Japan. |
| FDA record | Open on fda.gov |