St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Recall
- Recall Number
- Z-2348-2024
- Event Number
- 94613
- Firm
- St. Jude Medical
- FEI Number
- 2182269
- Product Code
- DYB
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- April 30, 2024
- Posted
- July 12, 2024
- Address
- 14901 Deveau Pl, Minnetonka, MN, 55345-2126
Description
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
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.
US and Canada
129 units