Z-2348-2024Class II

St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

Name: Z-2348-2024 St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Creator: St. Jude Medical
Published: 2024-04-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2024-04-30 / Open, Classified

FDA source

St. Jude Medical began a recall of St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 on 2024-04-30. FDA classified it as Class II and gives the reason as "One lot of product has dilators that are too short and will not extend outside the introducer sheath". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2348-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-30
Posted: 2024-07-12
Recalling firm: Abbott Medical
Product: St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Product code: DYB Introducer, Catheter
Reason for recall: One lot of product has dilators that are too short and will not extend outside the introducer sheath.
FDA root cause: Under Investigation by firm
Action: Abbott issued a MEDICAL DEVICE RECALL notice to its consignees on 04/31/2024 via FedEx and hand delivery. The notice explained the problem, risk, and requested the following: To reduce risk, Abbot recommends the following: - Do not use any remaining inventory from the identified affected lot. - Complete and return the accompanying Acknowledgment form to Abbott. - Return to Abbott all remaining unused devices from the affected lot. - For the notice to anyone to anyone within your organization who may need to be notified and maintain this notice for your records along with a copy of the completed Acknowledgement Form.
Quantity in commerce: 129 units
Distribution: US and Canada
Product codes and lots: UDI/DI 05414734206099, Lot Number 10071090

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2348-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2348-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12

Product code DYB

K061363Class IIAgilis Nxt Steerable IntroducerSt Jude Medical / cleared 2006-07-12

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)