Z-0217-2024 Class II
FDA device recall Z-0217-2024 was initiated by Medtronic Neuromodulation on May 27, 2022 and is designated Class II. 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… Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 8, 2023
- Initiation Date
- May 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
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.
Distribution Pattern
US: MO, FL, TX, WA
Code Information
UDI/DI 00763000274320, Serial Number VA2JV2V
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0217-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026