Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
St. Jude Medical Agilis NxT Steerable Introducer Recalled by St. Jude Medical Due to One lot of product has dilators that are...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact St. Jude Medical directly.
Affected Products
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Quantity: 129 units
Why Was This Recalled?
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Where Was This Sold?
US and Canada
About St. Jude Medical
St. Jude Medical has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report