FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Recall number
- Z-0217-2024
- Recalling firm
- Medtronic Neuromodulation
- Product
- LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Status
- Completed
- Initiated
- 2022-05-27
- Posted
- 2023-11-03
- Terminated
- not on file
- Reason
- There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
- Root cause
- Labeling Change Control
- Action
- Medtronic issued a Medical Device Removal notice to its consignees on 05/27/2023 by US mail. The notice explained the issue, potential risk, and requested the return of the affected product.
- Quantity
- 14 units
- Distribution
- US: MO, FL, TX, WA
- Lot, serial or model codes
- UDI/DI 00763000274320, Serial Number VA2JV2V
- 510(k) numbers
- not on file
- PMA numbers
- ["P960009"]
- Product code
- MHY
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- 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