Z-0217-2024Class II

LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device

Name: Z-0217-2024 LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device
Creator: Medtronic Neuromodulation
Published: 2022-05-27
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2022-05-27 / Completed / root cause: labeling and UDI

FDA source

Medtronic Neuromodulation began a recall of LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device on 2022-05-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0217-2024
Classification: Class II
Status: Completed
Initiated: 2022-05-27
Posted: 2023-11-03
Recalling firm: Medtronic Neuromodulation
Product: LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 14 units
Distribution: US: MO, FL, TX, WA
Product codes and lots: UDI/DI 00763000274320, Serial Number VA2JV2V

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0217-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0217-2024	Class II	Completed	Voluntary: Firm initiated	2023-11-08	2023-11-02

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)