LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Reported: November 8, 2023 Initiated: May 27, 2022 #Z-0217-2024
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 14 units
- Distribution
- US: MO, FL, TX, WA
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.. Recalled by Medtronic Neuromodulation. Units affected: 14 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 8, 2023. Severity: Moderate. Recall number: Z-0217-2024.
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