Z-1426-04

Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with...

Name: Z-1426-04 Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with...
Creator: St. Jude Medical/Daig Division
Published: 2004-08-04
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-08-04 / Terminated

FDA source

St. Jude Medical/Daig Division began a recall of Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The... on 2004-08-04. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1426-04
Status: Terminated
Initiated: 2004-08-04
Posted: 2004-09-01
Terminated: 2005-11-21
Recalling firm: Abbott Medical
Product: 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.
Product code: DYB Introducer, Catheter
Reason for recall: 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: 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 in commerce: 55 kits
Distribution: US, Canada, Belgium, Hong Kong, and Japan.
Product codes and lots: 1063074 - Exp Date: 03/2007, 1075104, - Exp. Date: 05/2007, 1076753 - Exp. Date: 06/2007

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)