Recall Z-0217-2024— Medtronic Neuromodulation
Class II · Completed
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2022-05-27. FDA's recall record names no specific 510(k) clearance for this event. Product: LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.. 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Completed
- Initiated
- 2022-05-27
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.