Summary
The FDA issued a Class II for St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 by St. Jude Medical. Reason: One lot of product has dilators that are too short and will not extend outside the introducer sheath..
Details
Source
Device Recall
External ID
Z-2348-2024
Action Date
2024-07-24
Status
Ongoing
Category
device
Product Description
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Lot/Code Info: UDI/DI 05414734206099, Lot Number 10071090
Quantity Affected: 129 units
Reason for Recall
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Distribution
US and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-30
Company
Minnetonka, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 198 device recalls issued in the same week, part of 403 device-related FDA actions this month.
St. Jude Medical has 13 FDA actions in our database, including 13 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (St. Jude Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does St. Jude Medical have FDA actions?
St. Jude Medical has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2348-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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