Reported Jul 24, 2024 · Ongoing
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
St. Jude Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical · 14901 Deveau Pl · Minnetonka, MN · 55345-2126
Is this the product you have?
- St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
- Lot codes and dates
UDI/DI 05414734206099Lot Number 10071090
- Amount recalled
- 129 units
Why it was recalled
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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