Depth Electrode RD16R-SP03X-000Recalls & reported problems
Ad-Tech Medical Instrument Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841823109026), received between Jan 31, 2025 and Jan 31, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 31, 2025Material Fragmentation; Material Fragmentation
PATIENT HAD SEEG SURGERY ON THURSDAY (B)(6) 2025. AFTER EXPLANTING ELECTRODES IN THE OR SURGICALLY THE PATIENT WAS SENT FOR A CT SCAN (ROUTINE PROCEDURE FOR THE HOSPITAL).. THERE WERE NO ISSUES DURING REMOVAL OF THE ELECTRODES, THEY WERE EXPLANTED WITHOUT INCIDENT. THE SCAN REVEALED THAT A METAL FRAGMENT REMAINED IN THE BRAIN. SCANS PRIOR TO IMPLANT DID NOT SHOW THAT THE METAL FRAGMENT EXISTED SO IT WAS ASSUMED THAT THIS WAS PART OF THE ELECTRODE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282549 ↗
Other ELECTRODE, DEPTH devices
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- Spencer Probe Depth Electrode SD08R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- Spencer Probe Depth Electrode SD04R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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