CLASS II ONGOING Device recall · Reported 24 Jul 2024 · FDA Enforcement Report
Agilis NxT Steerable Introducer recalled by St. Jude Medical
St. Jude Medical is recalling Agilis NxT Steerable Introducer. The recall was initiated on 30 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2348-2024
- FDA event ID
- 94613
- Recalling firm
- St. Jude Medical, Minnetonka, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2024
- FDA classified
- 12 Jul 2024
- Reported
- 24 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Apr 2024 | Recall initiated by company | |
| 12 Jul 2024 | Classified by FDA | +73 days |
| 24 Jul 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Product as listed by the FDA
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Where it was distributed
US and Canada
Questions about this recall
Why was it recalled?
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Which lots are affected?
UDI/DI 05414734206099, Lot Number 10071090
Where was it sold?
US and Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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