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NA MICRODEEP DEPTH ELECTRODE (REF D08-15AM)Recalls & reported problems

Dixi Medical · SEEG DEPTH ELECTRODE, 15 CONTACTS, EXPLORATION LENGTH 51MM, Ø 0.8MM, LONG LENGTH · Class 2

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

8 other recalls cover devices cleared under the same FDA submission (K170959); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Dec 9, 2021Terminated

    Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag

    Z-0538-2022 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170959. One submission often covers many models, so check the product and lot details in each record.

  • Z-0535-2022 · Dec 9, 2021 · Terminated
    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 electro
  • Z-0541-2022 · Dec 9, 2021 · Terminated
    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 electro
  • Z-0539-2022 · Dec 9, 2021 · Terminated
    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 electro
  • Z-0542-2022 · Dec 9, 2021 · Terminated
    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 electro
  • Z-0540-2022 · Dec 9, 2021 · Terminated
    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 electro
  • Z-0536-2022 · Dec 9, 2021 · Terminated
    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 electro
  • Z-0537-2022 · Dec 9, 2021 · Terminated
    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 electro
  • Z-0534-2022 · Dec 9, 2021 · Terminated
    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 electro

Other Electrode, Depth devices

All Electrode, Depth devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.