Recall Z-2348-2024— St. Jude Medical

Name: FDA recall Z-2348-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-30

Class II · Ongoing

Class II FDA medical device recall by St. Jude Medical, initiated 2024-04-30. It names one FDA 510(k) clearance: K061363. Product: 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..

Recalling firm: St. Jude Medical
Classification: Class II
Status: Ongoing
Initiated: 2024-04-30
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K061363 — AGILIS NXT STEERABLE INTRODUCERSt Jude Medical·cleared 2006-07-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.