microTargeting™ Platform MP-KIT-P-EO-00596Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00873263005965), received between Jul 13, 2021 and May 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Inaccurate Information

  A COMPLAINT WAS RECEIVED ON (B)(6) 2026, FOR A MULTI OBLIQUE EPILEPSY PLATFORM (MP-KIT-P-EO, SN (B)(6) USED ON (B)(6) 2026. THE REPORTING PHYSICIAN IDENTIFIED A DISCREPANCY BETWEEN THE DEPTH EMBOSSED ON THE PLATFORM (177 MM) AND THE CORRECT DEPTH PROVIDED IN THE PLANNING DOCUMENTATION (117 MM). THE DISCREPANCY WAS RECOGNIZED PRIOR TO USE, PREVENTING POTENTIAL MISPLACEMENT OF THE LEAD. INVESTIGATION DETERMINED THAT THE CORRECT DEPTH WAS PRESENT IN THE PLANNING SOFTWARE OUTPUTS AND MANUFACTURING DOCUMENTATION. THE DISCREPANCY WAS INTRODUCED DURING MANUAL TRANSCRIPTION OF DEPTH VALUES ONTO THE PLATFORM. DEVICE HISTORY RECORDS SHOWED ALL REQUIRED INSPECTIONS AND RELEASE STEPS WERE COMPLETED; HOWEVER, THE INCORRECT VALUE WAS NOT IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315475 ↗
• MalfunctionMay 27, 2026Use of Device Problem

  ON (B)(6), 2026, AN SEEG PROCEDURE WAS PERFORMED WITH 14 PLANNED TRAJECTORIES AND ONE ADDITIONAL GROUND ELECTRODE, WHICH WAS NOT INCLUDED IN THE NAVIGATION PLAN. THE PROCEDURE WAS DELAYED AND BEGAN AT APPROXIMATELY 7:00 PM. MEASUREMENTS WERE PROVIDED INTRAOPERATIVELY FOR BOTH THE TRACKING STYLET AND THE IMPLANTABLE LEAD. THE TRACKING STYLET WAS ADVANCED TO THE INTENDED DEPTH RELATIVE TO THE PLATFORM HUB. IMPLANTABLE LEADS WERE THEN ADVANCED USING DEPTH MARKINGS ON THE LEAD IN CONJUNCTION WITH THE FIXATION BOLT. FOLLOWING PLACEMENT OF ALL LEADS, INTRAOPERATIVE CT IMAGING INDICATED THAT ALL WERE POSITIONED APPROXIMATELY 4-5 CM DEEPER THAN INTENDED. A CONFIRMATORY CT SCAN PERFORMED IN RADIOLOGY VERIFIED THE FINDING. ALL LEADS WERE SUBSEQUENTLY REMOVED. NO INTRACRANIAL HEMORRHAGE WAS IDENTIFIED ON IMAGING. THE PROCEDURE WAS DISCONTINUED AND NOT COMPLETED AS PLANNED. POST-PROCEDURE FOLLOW-UP AT APPROXIMATELY 72 HOURS INDICATED THE PATIENT EXPERIENCED NO ADVERSE EFFECTS OR COMPLICATIONS. THE PHYSICIAN ACKNOWLEDGED OPERATOR USE ERROR AS THE LIKELY CAUSE AND EXPRESSED INTENT TO PURSUE ADDITIONAL TRAINING PRIOR TO FUTURE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25305898 ↗
• MalfunctionJul 13, 2021Inaccurate Information; Inaccurate Information

  WHILE USING A MP-KIT-P-EO (MULTIOBLIQUE (PMT) WAYPOINT STEREOTACTIC SYSTEM, PHYSICIAN FOUND THE PLATFORM WAS LABELED WITH THE INCORRECT DEPTH NUMBERS. THERE WAS NO HARM TO PATIENT AS PHYSICIAN IDENTIFIED THE ISSUE AND PROCEEDED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12160501 ↗