AxiEM™ 9735428Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000588489), received between Feb 8, 2023 and May 2, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE STYLET WAS INTERMITTENTLY TRACKING. IT WAS BELIEVED TO BE AN OUT OF BOX FAILURE. TROUBLESHOOTING WAS PERFORMED. THE LOCAL REPRESENTATIVE (CS) RESEATED CONNECTIONS FOR THE BREAK OUT BOX (BOB) AND STYLET WITH NO RESOLUTION. THE CS MOVED THE SIDE EMITTER UP AWAY FROM THE PATIENT AND TRIED TO TRACK WITH NO RESOLUTION. THEY OPENED A NEW STYLET AND THE ISSUE RESOLVED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955110 ↗
• MalfunctionFeb 21, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM. IT WAS REPORTED THAT THE EM STYLET WAS PLUGGED INTO THE INSTRUMENT INTERFACE AND THE PORT TURNED GREEN BUT IT WOULD NOT TRACK OR POPULATE WITHIN THE SOFTWARE. THE MANUFACTURING REPRESENTATIVE (REP) TRIED PLACING IT IN OTHER PORTS ON THE INSTRUMENT INTERFACE BOX THAT HE KNEW WORKED WITH NO CHANGE. THE SITE OPENED ANOTHER EM STYLET AND THE ISSUE RESOLVED. THERE WAS NO PATIENT IMPACT AND A 5 MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434051 ↗
• MalfunctionFeb 20, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE STYLET FAILED TO TRACK. A MANUFACTURING REPRESENTATIVE STATED HE HAD TRIED DIFFERENT PORTS ON THE BREAKOUT BOX, BUT EVENTUALLY SWAPPED FOR A NEW STYLET WHICH WORKED RIGHT AWAY. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424665 ↗
• MalfunctionFeb 20, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE STYLET WAS TRACKING WHILE IN NAVIGATION AND THEN STOPPED TRACKING WHILE STILL IN NAVIGATION. SITE WAS USING A NON-INVASIVE PATIENT TRACKER AND A FLAT EMITTER. ISSUE WAS RESOLVED WHEN A NEW STYLET WAS OPENED. THE SITE REPORTED NO METAL IN THE FIELD, AND ATTEMPTED TO PLUG THE STYLET INTO MULTIPLE DIFFERENT PORTS ON THE BREAK OUT BOX WITH NO EFFECT. TECHNICAL SERVICES (TS) HAD SITE CONFIRM THAT THE STYLET WAS INCLUDED IN THE INSTRUMENTS TAB FOR THE PROCEDURE. SITE REPORTED THAT THE STYLET WAS GREEN IN THE INSTRUMENTS TAB AND RED IN THE NAVIGATION TASK. TS HAD THE SITE BRING IN A "PENCIL" (REGISTRATION PROBE) TO USE IN THE SAME PORTS ON THE BREAK OUT BOX. SITE CONFIRMED THAT THE PROBE WAS TRACKING WHEN PLUGGED INTO THE SAME PORTS THAT THE STYLET HAD BEEN PLUGGED INTO. TS ADVISED SITE TO OPEN A NEW STYLET. THIS RESULTED IN A LESS THAN 30 MIN DELAY TO THE CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424047 ↗
• MalfunctionOct 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT REGISTRATION AND NAVIGATION WENT SMOOTHLY. IN THE POST OPERATIVE COMPUTED TOMOGRAPHY (CT)CONTROL IT WAS NOTICED THAT THE DRAINAGE HAD NOT BEEN PLACED AT THE PLANNED TARGET. THE SITE HAD TO DO A REINTERVENTION, BUT HAD TO USE A PASSIVE CATHETER INTRODUCER (PCI) TIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY THE SECOND TIME. THERE WAS AN INACCURACY OF 4MM, THE DIRECTION OF INACCURACY WAS NOT SPECIFIED. INACCURACY OCCURRED DURING NAVIGATION AND WAS ISOLATED TO JUST THE STYLET INSTRUMENT. THERE WAS NO SURGICAL DELAY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558926 ↗
• MalfunctionAug 12, 2024Mechanical Problem; Device Sensing Problem; Mechanical Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE STYLET FAILED OUT OF THE BOX. THE SITE TRIED PLUGGING INTO MULTIPLE PORTS. THE REFERENCE WAS RECOGNIZED BY THE SYSTEM BUT WOULD NOT SEE STYLET. A NEW STYLET WORKED FINE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19962174 ↗
• MalfunctionJul 17, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING REGISTRATION, THERE WAS NO PROBLEM CONNECTING/VIEWING THE TRACER POINTER OR THE NON INVASIVE REFERENCE. LATER IN SURGERY ITSELF, FIRST THE STYLET WAS NOT VISUALIZED WHEN CONNECTED (THERE WAS NO INTERFERING METAL).  THEN, WHEN CONNECTING THE STYLET IN ANOTHER PORT, IF THE STYLET WAS CONNECTED IT WOULD INTERFERE AND THE REFERENCE WAS LOST. THE SITE TRIED IN EVERY PORT, UNTIL IN ONE CONNECTION, BOTH INSTRUMENTS WERE VISUALIZED, BUT THE DOCTOR HAD DECIDED TO PLACE THE CATHETER WITHOUT NAVIGATION. THE USE OF NAVIGATION WAS DISCONTINUED. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761649 ↗
• MalfunctionFeb 8, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION INSTRUMENT DURING A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT DURING A CASE, THE STYLET WOULD NOT TRACK AT ALL. THE TRACER TRACKED WITHOUT PROBLEM AND REGISTRATION WENT FINE. WHEN BRINGING THE STYLET INTO THE FIELD, THE SITE SAW NO GEOMETRY ERROR METRIC AT ALL. THE SURGEON DECIDED TO MOVE ON WITHOUT NAVIGATING THE STYLET. AFTER THE CASE, THE CLINICAL CONSULTANT (CC) TOOK THE EMITTER OUT OF THE OPERATION AREA, BROUGHT IN ANOTHER PATIENT TRACKER AND STYLET, AND IT STILL DIDN'T TRACK. THERE WAS LESS THAN AN HOUR DELAY IN SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16327219 ↗