Recall Z-2348-2024 ยท DYB Introducer, Catheter
St. Jude Medical
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
| Date | Jul 12, 2024 (initiated Apr 30, 2024) |
| Status | Open, Classified |
| Reason | One lot of product has dilators that are too short and will not extend outside the introducer sheath. |
| Root cause | Under Investigation by 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 t |
| Quantity | 129 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061363 | AGILIS NXT STEERABLE INTRODUCER St Jude Medical, Jul 12, 2006 |