St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
FDA Recall Z-2348-2024 · Posted 2024-07-12
Recalling FirmSt. Jude Medical
Recall StatusOpen, Classified
Product CodeDYB
Date Initiated2024-04-30
Product Quantity129 units
Reason for Recall
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.