FDA-Device2024-07-24Class II
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
St. Jude Medical
Hazard
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Sold states
US and Canada
Affected count
129 units
Manufactured in
14901 Deveau Pl, Minnetonka, MN, United States
Products
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2348-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief