FDA Enforcement
Class II
Ongoing
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Recall: Z-2348-2024
·
Reported July 24, 2024
Enforcement
- Recall Number
- Z-2348-2024
- Event ID
- 94613
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- St. Jude Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 24, 2024
- Initiation Date
- April 30, 2024
- Classification Date
- July 12, 2024
- Address
- 14901 Deveau Pl, Minnetonka, MN, 55345-2126, United States
Description
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Reason
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Code Info
UDI/DI 05414734206099, Lot Number 10071090
Distribution
US and Canada
Quantity
129 units