The Recall Desk
HighFDA (Devices)·Z-2348-2024·Announced 2024-07-24

Agilis NxT Steerable Introducer Recalled for Dilators Too Short

St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer due to dilators that are too short and will not extend outside the introducer sheath. The defect may prevent proper device function.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of a medical device with a functional defect that prevents proper operation. No illnesses or injuries have been reported. The defect represents a risk-of-harm situation in a surgical device.

Plain-English summary

St. Jude Medical is recalling 129 units of the Agilis NxT Steerable Introducer (REF 408309) from one lot. The affected units contain dilators that are too short and will not extend outside the introducer sheath.

This defect prevents the dilators from operating as designed, potentially affecting the device's functionality and proper placement.

The recalled units were distributed in the United States and Canada. The recalled lot number is 10071090 (UDI/DI 05414734206099).

Customers who have received or used units from this lot should contact St. Jude Medical for further instructions regarding return or replacement.

The recalled product

Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Manufacturer
St. Jude Medical
Category
Medical Device
Hazard
  • device-malfunction
  • improper-extension

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI/DI 05414734206099
  • Lot Number 10071090

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category