St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
This recall is currently active, issued July 12, 2024. It was issued by St. Jude Medical.
- Company
- St. Jude Medical
- Recall Initiated
- April 30, 2024
- Posted
- July 12, 2024
- Recall Number
- Z-2348-2024
- Quantity
- 129 units
- Firm Location
- Minnetonka, MN
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
Distribution
US and Canada
Lot / Code Info
UDI/DI 05414734206099, Lot Number 10071090
Root Cause
Under Investigation by firm
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.