St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
FDA device recall Z-2348-2024 · posted 2024-07-12 · Open, Classified
Recall details
- Recalling firm
- St. Jude Medical
- Reason for recall
- One lot of product has dilators that are too short and will not extend outside the introducer sheath.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DYB
- Quantity affected
- 129 units
- Distribution
- US and Canada
- Date initiated
- 2024-04-30
- Date posted
- 2024-07-12
- Location
- Minnetonka, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AGILIS NXT STEERABLE INTRODUCER (K061363) | St Jude Medical | 2006-07-12 |