Z-0535-2007

FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical...

Name: Z-0535-2007 FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical...
Creator: St. Jude Medical / Daig Division
Published: 2006-10-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-10-05 / Terminated

FDA source

St. Jude Medical / Daig Division began a recall of FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and... on 2006-10-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0535-2007
Status: Terminated
Initiated: 2006-10-05
Posted: 2007-03-01
Terminated: 2007-05-25
Recalling firm: Abbott Medical
Product: FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
Product code: DYB Introducer, Catheter
Reason for recall: 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.
FDA root cause: Other
Action: The affected customers were notified on 10/5/06 by letter.
Quantity in commerce: 40 Units
Distribution: Nationwide.
Product codes and lots: Lot number 1239904

Product code DYB

K964518Class IIFast-Cath Transseptal Catheter IntroducerDaig Corp. / cleared 1997-05-14

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)