FDA Medical Device Recalls (openFDA)
St. Jude Medical: St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
- Recall number
- Z-2348-2024
- Recalling firm
- St. Jude Medical
- Product
- St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
- Status
- Open, Classified
- Initiated
- 2024-04-30
- Posted
- 2024-07-12
- Terminated
- not on file
- 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 the completed Acknowledgement Form.
- Quantity
- 129 units
- Distribution
- US and Canada
- Lot, serial or model codes
- UDI/DI 05414734206099, Lot Number 10071090
- 510(k) numbers
- ["K061363"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 2182269
- Firm city
- Minnetonka
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28