Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2348-2024 — St. Jude Medical Agilis NxT Steerable Introducer, REF 408309

U.S. FDA — Device Enforcement · United States · 2024-04-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2348-2024
Date of alert
2024-04-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
St. Jude Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05414734206099
Reported risk: One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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