CRANIALMAP 6000-660-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327327199), received between Nov 19, 2018 and Oct 21, 2025 — classified as 1 injury, 21 malfunctions.

The most frequently reported specific device problem is “Imprecision” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Imprecision; Imprecision

  DURING A CASE USING THE CRANIALMAP SOFTWARE, THE NAVIGATION APPEARED TO BE INACCURATE BY MORE THAN ONE CENTIMETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 3 MINUTES AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350255 ↗
• InjuryMay 12, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE CRANIAL MAP 3.0 SOFTWARE, THE NAVIGATION WAS INACCURATE. THERE WAS A SURGICAL DELAY OF 15 MINUTES AND THE PATIENT WAS REPORTED TO HAVE SUFFERED NEUROLOGICAL DAMAGE.

  Patient problems: Brain Injury

  MAUDE report 22005495 ↗
• MalfunctionMar 7, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE, WHEN THE SURGEON ENTERED THE NASAL PASSAGE, THE ACCURACY WAS OFF BY 1 CENTIMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21551673 ↗
• MalfunctionFeb 6, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE CRANIAL MAP SOFTWARE, THERE WAS AN INACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322849 ↗
• MalfunctionFeb 4, 2025Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CRANIOTOMY USING THE CRANIAL MAP SOFTWARE, THE ACCURACY WAS OFF BY AT LEAST 1 CENTIMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21304734 ↗
• MalfunctionAug 28, 2024Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE CRANIAL MAP SOFTWARE, THE REGISTRATION WAS INACCURATE WHEN THE SURGEONS WERE TRANSNASAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092157 ↗
• MalfunctionJul 31, 2024Display or Visual Feedback Problem; Imprecision; Display or Visual Feedback Problem; Imprecision

  IT WAS REPORTED THAT DURING A CASE USING THE CRANIALMAP SOFTWARE, THE VIRTUAL TIP WOULD MOVE UP AND DOWN BEFORE COMING BACK TO THE ORIGINAL LOCATION ON THE SKULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19875952 ↗
• MalfunctionOct 4, 2023Imprecision; Incorrect Measurement; Imprecision; Incorrect Measurement

  PER THE CUSTOMER, THERE WAS AN "INTRAOP NAVIGATION INACCURACY," ISSUE WITH THE DEVICE. THE NAVIGATION DEVICE SHOWED DIFFERENT LOCATION IN AXIAL, CORONAL AND SAGITTAL VIEWS, WITH RESPECT TO PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871045 ↗
• MalfunctionAug 3, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE NAVIGATION WAS INACCURATE AND COULD NOT FIND THE TARGET AREA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451175 ↗
• MalfunctionJul 24, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER DURING A NAVIGATED CRANIAL CASE WITH THE NAV3I, THE SURGEON FELT THE SYSTEM WAS SHOWING THE INSTRUMENT AT A DIFFERENT DEPTH THAN WHERE HE FELT HE WAS. THE SURGEON CONTINUED WITH THE CASE AND WANTED TO WAIT UNTIL AFTER THE CASE TO TROUBLESHOOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377579 ↗
• MalfunctionMay 26, 2022Imprecision; Device Handling Problem; Imprecision; Device Handling Problem

  PER THE SALES REPRESENTATIVE THAT WAS PRESENT DURING THE CASE, IMAGES FROM A PREVIOUS PROCEDURE WERE LOADED ONTO THE DEVICE AT START UP, WHICH COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515784 ↗
• MalfunctionMay 12, 2022Imprecision; Imprecision

  PER THE CUSTOMER, WHILE THE SURGEON WAS HOLDING A NAVIGATION TOOL STILL IT SHOWED FLUTTERING ON THE DISPLAY MONITOR, WHICH COULD LEAD TO INACCURACIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376145 ↗
• MalfunctionMay 24, 2021Unintended Application Program Shut Down; Intermittent Communication Failure; Unintended Application Program Shut Down; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THERE WERE MULTIPLE BLUE SCREENS DURING A CRANIOTOMY CASE. THE CASE WAS COMPLETED WITH A MINOR DELAY, BUT THE IMAGES WERE INACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871340 ↗
• MalfunctionApr 22, 2021Display or Visual Feedback Problem; Intermittent Communication Failure; Display or Visual Feedback Problem; Intermittent Communication Failure

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE CUSTOMER UNKNOWINGLY UPLOADED AN IMAGE SET FOR ONE PATIENT INTO THE CASE-FOLDER OF A DIFFERENT PATIENT AND ATTEMPTED TO USE NAVIGATION. AS THE PATIENT LANDMARKS WOULD BE DISSIMILAR, AN INACCURACY COULD OCCUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712539 ↗
• MalfunctionFeb 26, 2021Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE WAS INACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386868 ↗
• MalfunctionFeb 16, 2021Imprecision; Imprecision

  IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE REGISTRATION OF THE CRANIALMASK WAS UNSUCCESSFUL AND SHOWED AN INACCURACY OF 1 INCH. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333781 ↗
• MalfunctionSep 2, 2020Imprecision; Imprecision

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY, AN INACCURACY OF 10-20 MILLIMETERS WAS OBSERVED WHEN THE CUSTOMER CHANGED FROM USING ONE POINTER TO A DIFFERENT POINTER. THE POSITION OF THE TUMOR APPEARED SHIFT. THE HOLE ON THE SKULL WAS EXPANDED TO ADDRESS THE SHIFT. THE CUSTOMER REPORTED "LARGE" BLEEDING, BUT ADDITIONAL BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION WAS REPORTED, AND THERE WERE NO ADVERSE CONSEQUENCES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10483484 ↗
• MalfunctionJul 2, 2019Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT THE NAV3I IS LOSING ACCURACY DURING CASES AND THE UNIT WAS NOT ABLE TO BE USED BECAUSE OF THE UNIT LOSING ACCURACY. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755074 ↗
• MalfunctionJul 1, 2019Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT THE NAV3I IS LOSING ACCURACY DURING CASES AND THE UNIT WAS NOT ABLE TO BE USED BECAUSE OF THE UNIT LOSING ACCURACY. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748318 ↗
• MalfunctionFeb 21, 2019Break; Break

  IT WAS REPORTED THAT THE 3D IMAGING OF THE DEVICE WAS FOUND TO BE INACCURATE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358000 ↗
• MalfunctionNov 19, 2018Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE CRANIAL SOFTWARE WAS NOT ACCURATE DURING CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085697 ↗
• MalfunctionNov 19, 2018Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE CRANIAL SOFTWARE WAS NOT ACCURATE DURING CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8085626 ↗