FDA recall Z-0217-2024

Medtronic Neuromodulation · Class II · device

Product

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

US: MO, FL, TX, WA

Key facts

Status: Completed
Initiation date: 2022-05-27
Report date: 2023-11-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0217-2024