FDA Device recall Z-0541-2022
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi…
- FDA Device
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter wi… by Dixi Medical Usa, citing potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0541-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-09 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Dixi Medical Usa |
| Distribution | US |
Product
The DIXI Medical Microdeep Depth Electrode ( Microdeep Depth Electrode or Electrode ) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Reason
Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag
Identifiers
| code_info | All lots UDI:03664539000176 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0541-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.