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U.S. Department of Health and Human Services

Class 2 Device Recall St. Jude Medical Agilis NxT Steerable Introducer

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 Class 2 Device Recall St. Jude Medical Agilis NxT Steerable Introducersee related information
Date Initiated by FirmApril 30, 2024
Date PostedJuly 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2348-2024
Recall Event ID 94613
510(K)NumberK061363 
Product Classification Introducer, catheter - Product Code DYB
ProductSt. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Code Information UDI/DI 05414734206099, Lot Number 10071090
FEI Number 2182269
Recalling Firm/
Manufacturer		 St. Jude Medical
14901 Deveau Pl
Minnetonka MN 55345-2126
For Additional Information ContactShelley Lange
651-756-4091
Manufacturer Reason
for Recall		One lot of product has dilators that are too short and will not extend outside the introducer sheath.
FDA Determined
Cause 2		Under Investigation by firm
ActionAbbott issued a MEDICAL DEVICE RECALL notice to its consignees on 04/31/2024 via FedEx and hand delivery. The notice explained the problem, risk, and requested the following: To reduce risk, Abbot recommends the following: - Do not use any remaining inventory from the identified affected lot. - Complete and return the accompanying Acknowledgment form to Abbott. - Return to Abbott all remaining unused devices from the affected lot. - For the notice to anyone to anyone within your organization who may need to be notified and maintain this notice for your records along with a copy of the completed Acknowledgement Form.
Quantity in Commerce129 units
DistributionUS and Canada
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DYB
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