FDA recall Z-2348-2024
St. Jude Medical · Class II · device
Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Reason for recall
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Distribution
US and Canada
Key facts
- Status
- Ongoing
- Initiation date
- 2024-04-30
- Report date
- 2024-07-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minnetonka, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2348-2024