Z-0108-2015Class II

St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio"...

Name: Z-0108-2015 St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio"...
Creator: St Jude Medical
Published: 2014-10-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-10-14 / Terminated / root cause: manufacturing process

FDA source

St Jude Medical began a recall of St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following... on 2014-10-14. FDA classified it as Class II and gives the reason as "St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire...". 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-0108-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-14
Posted: 2014-10-22
Terminated: 2015-03-25
Recalling firm: Abbott Medical
Product: St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.
Product code: DYB Introducer, Catheter
Reason for recall: St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: St. Jude Medical sent an Urgent Medical Device Recall Notice dated October 14, 2014, to all affected consignees. The letter described the problem and the product affected by the recall. Advised consignees to discontinue us of the device. A St. Jude Medical sales representative were to contact the consignee in the near future to facilitate removal and reconciliation of the recalled device. Customers with questions were instructed to contact their St. Jude Medical sales Representative. For questions regarding this recall call 651-756-2295.
Quantity in commerce: 220
Distribution: Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.
Product codes and lots: Batch 4641580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0108-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0108-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-21

Product code DYB

K954317Class IIDiag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/sideports & 3-Way StopcocksDaig Corp. / cleared 1995-11-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)