St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Reported: July 24, 2024 Initiated: April 30, 2024 #Z-2348-2024
Product Description
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.
Details
- Recalling Firm
- St. Jude Medical
- Units Affected
- 129 units
- Distribution
- US and Canada
- Location
- Minnetonka, MN
Frequently Asked Questions
What product was recalled? ▼
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309. Recalled by St. Jude Medical. Units affected: 129 units.
Why was this product recalled? ▼
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2024. Severity: Moderate. Recall number: Z-2348-2024.
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