Telesheath Left Atrial Introducer System Right Superior.… recallZ-1426-04 · St. Jude Medical/Daig Division · initiated Aug 4, 2004
Terminated All recalls posted in September 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St. Jude Medical/Daig Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1426-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 4, 2004
- Posted by the FDA
- Sep 1, 2004
- Recalling firm
- St. Jude Medical/Daig Division
- Quantity
- 55 kits
- Product code
- DYB
- FDA submissions
- K964518, K973840, K982187
- Distribution
- US, Canada, Belgium, Hong Kong, and Japan.
Product description
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.
Code information (models, lots, serial numbers)
1063074 - Exp Date: 03/2007, 1075104, - Exp. Date: 05/2007, 1076753 - Exp. Date: 06/2007
Other devices under the same FDA submission
8 devices cleared under K964518, K973840, K982187 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fast-Cath™ 406948St. Jude Medical, Inc. · INTRODUCER, CATHETER42 reports
- Fast-Cath™ 406842St. Jude Medical, Inc. · INTRODUCER, CATHETER3 reports
- Fast-Cath™ 406898St. Jude Medical, Inc. · INTRODUCER, CATHETER2 reports
- Fast-Cath™ 407436St. Jude Medical, Inc. · INTRODUCER, CATHETER2 reports
- Fast-Cath™ 406885St. Jude Medical, Inc. · INTRODUCER, CATHETER1 report
- Fast-Cath™ 406965St. Jude Medical, Inc. · INTRODUCER, CATHETER1 report
- Fast-Cath™ 406851St. Jude Medical, Inc. · INTRODUCER, CATHETER1 report
- Fast-Cath™ 406949St. Jude Medical, Inc. · INTRODUCER, CATHETER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 29848).
- Z-1425-04 · TerminatedTelesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packa…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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