St. Jude Medical St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Brand
St. Jude Medical
Lot Codes / Batch Numbers
UDI/DI 05414734206099, Lot Number 10071090
Products Sold
UDI/DI 05414734206099, Lot Number 10071090
St. Jude Medical is recalling St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 due to One lot of product has dilators that are too short and will not extend outside the introducer sheath.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Recommended Action
Per FDA guidance
Abbott 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026