St. Jude Medical/Daig Division Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. 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.
Brand
St. Jude Medical/Daig Division
Lot Codes / Batch Numbers
1063073 - Exp. Date: 03/2007, 1075105, - Exp. Date: 05/2007 1077015 - Exp. Date: 06/2007, 1079062 - Exp Date: 06/2007
Products Sold
1063073 - Exp. Date: 03/2007, 1075105, - Exp. Date: 05/2007 1077015 - Exp. Date: 06/2007, 1079062 - Exp Date: 06/2007
St. Jude Medical/Daig Division is recalling Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer K due to St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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