N/A 9735428Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169490468), received between Apr 9, 2019 and Feb 26, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Contamination

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN CONTEXT. IT WAS REPORTED THAT THE AXIEM WAS NOT STERILE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED PRIOR TO A CATHETER PLACEMENT PROCEDURE. IT WAS CLARIFIED THAT THE STYLET CAME WITHOUT THE STERILITY SEAL CLOSED ON THE PACKAGING, NOR WAS IT MANIPULATED. THE PROCEDURE WAS COMPLETED USING ANOTHER CONSUMABLE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455759 ↗
• MalfunctionMar 12, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE STYLET WAS NOT RECOGNIZED BY NAVIGATION. THERE WAS A TRACKING ISSUE EXPERIENCED WITH THE STYLET. THE SYSTEM DID NOT RECOGNIZE THE NAME OF THE INSTRUMENT IN THE SOFTWARE. A DIFFERENT STYLET WAS NEEDED TO BE USED. THE SUSPECTED CAUSE OF THE EVENT WAS UNKNOWN. NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888769 ↗
• MalfunctionJul 26, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN PREPARING FOR A CASE THE SITE OPENED AN EM STYLET AND IT WAS BENT IN THE PACKAGING. SITE OPENED ANOTHER STYLET. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103497 ↗
• InjuryNov 15, 2021Biocompatibility; Biocompatibility

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT AN INFECTION OCCURRED DURING THE PROCEDURE UTILIZING THE NAVIGATION STYLET. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 12814769 ↗
• InjuryNov 15, 2021Biocompatibility; Biocompatibility

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT AN INFECTION OCCURRED DURING THE PROCEDURE UTILIZING THE NAVIGATION STYLET. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 12814757 ↗
• MalfunctionNov 5, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY OF A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THEY COULD NOT SEE THE STYLETS. THEY USED ONE STYLET THAT DIDN'T DETECT AT ALL. THEY OPENED A SECOND STYLET WHICH DETECTED FOR 3 PASSES, THEN PICKING IT UP AGAIN, IT NO LONGER DETECTED. THEY OPENED A THIRD STYLET THAT DETECTED FOR 3 PASSES THEN STOPPED DETECTING. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. THE SURGERY WAS COMPLETED WITH THE USE OF A C-ARM. THE TRACKING ISSUE WAS THOUGHT TO BE RELATED TO THE STYLETS AS THE SYSTEM NEVER LOST THE PATIENT TRACKER AND THE STYLET WAS GREEN ON THE INSTRUMENT SCREEN, WHICH INDICATED IT WAS PLUGGED INTO THE EMITTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9282248 ↗
• MalfunctionNov 5, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY OF A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THEY COULD NOT SEE THE STYLETS. THEY USED ONE STYLET THAT DIDN'T DETECT AT ALL. THEY OPENED A SECOND STYLET WHICH DETECTED FOR 3 PASSES, THEN PICKING IT UP AGAIN, IT NO LONGER DETECTED. THEY OPENED A THIRD STYLET THAT DETECTED FOR 3 PASSES THEN STOPPED DETECTING. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. THE SURGERY WAS COMPLETED WITH THE USE OF A C-ARM. THE TRACKING ISSUE WAS THOUGHT TO BE RELATED TO THE STYLETS AS THE SYSTEM NEVER LOST THE PATIENT TRACKER AND THE STYLET WAS GREEN ON THE INSTRUMENT SCREEN, WHICH INDICATED IT WAS PLUGGED INTO THE EMITTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9282140 ↗
• MalfunctionNov 5, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY OF A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THEY COULD NOT SEE THE STYLETS. THEY USED ONE STYLET THAT DIDN'T DETECT AT ALL. THEY OPENED A SECOND STYLET WHICH DETECTED FOR 3 PASSES, THEN PICKING IT UP AGAIN, IT NO LONGER DETECTED. THEY OPENED A THIRD STYLET THAT DETECTED FOR 3 PASSES THEN STOPPED DETECTING. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME. THE SURGERY WAS COMPLETED WITH THE USE OF A C-ARM. THE TRACKING ISSUE WAS THOUGHT TO BE RELATED TO THE STYLETS AS THE SYSTEM NEVER LOST THE PATIENT TRACKER AND THE STYLET WAS GREEN ON THE INSTRUMENT SCREEN, WHICH INDICATED IT WAS PLUGGED INTO THE EMITTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9282123 ↗
• MalfunctionApr 9, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CATHETER PLACEMENT PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT THERE WAS NO PROBLEM TILL REGISTRATION. THE OPERATIVE FIELD BECAME STERILE AND WHEN THE STYLET GOT CLOSE TO THE STERILE OPERATIVE FIELD, THE RECOGNITION WAS UNSTABLE. ADJUSTING THE POSITION OF METAL AND EMITTER WAS PERFORMED, BUT NO IMPROVEMENT WAS SEEN. THE PROCEDURE WAS COMPLETED WITH THE CONTINUOUS USE OF THE NAVIGATION SYSTEM AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495824 ↗