Device product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Z-2348-2024
Product summary
- Firm
- St. Jude Medical
- Event
- Event 94613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 129 units
- Official record key
device-enforcement:Z-2348-2024
Official wording
Reason: One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Code information: UDI/DI 05414734206099, Lot Number 10071090
Distribution pattern: US and Canada
Derived failure modes
-
Unknown
One lot of product has dilators that are too short and will not extend outside the introducer sheath.