Agilis recallZ-2348-2024 · St. Jude Medical · initiated Apr 30, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St. Jude Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One lot of product has dilators that are too short and will not extend outside the introducer sheath.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2348-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2024
- Posted by the FDA
- Jul 12, 2024
- Recalling firm
- St. Jude Medical
- Quantity
- 129 units
- Product code
- DYB
- FDA submissions
- K061363
- Distribution
- US and Canada
Product description
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Code information (models, lots, serial numbers)
UDI/DI 05414734206099, Lot Number 10071090
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Agilis™ 408309St. Jude Medical, Inc. · INTRODUCER, CATHETER1 recall3 deaths166 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K061363 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ 408310St. Jude Medical, Inc. · INTRODUCER, CATHETER2 deaths218 reports
- Agilis™ G408319St. Jude Medical, Inc. · INTRODUCER, CATHETER97 reports
- Agilis™ G408321St. Jude Medical, Inc. · INTRODUCER, CATHETER10 reports
- Agilis™ G408320St. Jude Medical, Inc. · INTRODUCER, CATHETER1 death7 reports
- Agilis™ G402049St. Jude Medical, Inc. · INTRODUCER, CATHETER3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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