microTargeting™ Platform MP-KIT-P-ED-00598Recalls & reported problems
Fhc, Inc. · microTargeting Multi-Oblique Dual Trajectory Platform, 1x, nonsterile · 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 00873263005989), received between Oct 29, 2020 and Oct 29, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequate or Insufficient Training” (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.
Most reported problems
Device problems
- Inadequate or Insufficient Training1
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.
MalfunctionOct 29, 2020Inadequate or Insufficient Training; Inadequate or Insufficient Training
PHYSICIAN STATED THAT HE HAD A SAFETY CONCERN REGARDING THE FHC MULTI OBLIQUE DUAL TRAJECTORY PLATFORM TARGETING GUIDES: "IN OUR OR THE OTHER DAY, DESPITE HAVING DONE MANY OF THESE CASES, THE WRONG NUMBER WAS READ-OUT (BIOPSY DEPTH RATHER THAN TARGET DEPTH), RESULTING IN A PLACEMENT THAT WAS 1CM TOO DEEP. FORTUNATELY, NO INJURY RESULTED (THE TIP WAS IN A CSF SPACE), BUT THERE WAS THE REAL POSSIBILITY OF DISASTER. I WOULD RECOMMEND THAT YOU EITHER 1) REMOVE THE BIOPSY DEPTH COLUMN AND SIMPLY NOTE SEPARATELY THAT BIOPSY DEPTH IS 10MM FURTHER (SOMETHING THAT SHOULD BE OBVIOUS TO ANYONE, ANYWAY), OR ELSE 2) SIMPLY WRITE IN THAT COLUMN "+10MM". THIS ISSUE WAS DUE TO USER ERROR, THE DEPTH SHEET WAS CORRECT AND DISPLAYED AS IT WAS INTENDED TO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10756146 ↗
Other Neurological stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 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.
How reports and recalls are matched · Editorial policy · Report an error on this page