Z-0617-2013Class III

Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude...

Name: Z-0617-2013 Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude...
Creator: St Jude Medical Inc
Published: 2012-03-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-03-28 / Terminated / root cause: manufacturing process

FDA source

St Jude Medical Inc began a recall of Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343... on 2012-03-28. FDA classified it as Class III and gives the reason as "St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0617-2013
Classification: Class III
Status: Terminated
Initiated: 2012-03-28
Posted: 2012-12-28
Terminated: 2013-07-12
Recalling firm: Abbott Medical
Product: Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Product code: DYB Introducer, Catheter
Reason for recall: St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer. The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction. Customers were requested to to complete and return the reconciliation form. Further questions please call (651) 756-6526
Quantity in commerce: 26
Distribution: US Distribution only including the states of FL, KY and OK.
Product codes and lots: Model no. 406586 Batch no. 3619533

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0617-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0617-2013	Class III	Terminated	Voluntary: Firm initiated	2013-01-09	2012-12-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)