SynergyRecalls & reported problems across all models

We found 9 models of Synergy by Medtronic Navigation, Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Sep 30, 2016 and May 23, 2025 — classified as 4 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (11 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Synergy recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 26, 2018Class ITerminated

   An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.

   Z-0552-2019 · Root cause: Device Design · names 8 of these models · Recall details · FDA record ↗

Most reported Synergy problems

Synergy models

9 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Synergy® 9733763

  Neurological stereotaxic Instrument
  1 recall0 reports
• Synergy® 9733937

  Neurological stereotaxic Instrument
  1 recall0 reports
• Synergy 9734048

  Neurological stereotaxic Instrument
  50 reports
• Synergy 9734068

  Neurological stereotaxic Instrument
  1 recall0 reports
• Synergy® 9733937

  Neurological stereotaxic Instrument
  1 recall0 reports
• Synergy® 9733937

  Neurological stereotaxic Instrument
  1 recall0 reports
• Synergy® 9733937

  Neurological stereotaxic Instrument
  1 recall0 reports
• Synergy® 9733937

  Neurological stereotaxic Instrument
  1 recall0 reports
• Synergy® 9733937

  Neurological stereotaxic Instrument
  1 recall0 reports

Recent Synergy adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE SURGEON WAS TRYING TO LOAD AN EXAM FROM THE PLANNING STATION TO THE NAVIGATION SYSTEM, THEY WERE EXPERIENCING AN ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077689 ↗
• MalfunctionApr 1, 2025Display or Visual Feedback Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Application Program Problem; Adverse Event Without Identified Device or Use Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A PROBLEM EXPERIENCED DURING SERVICING. AFTER THE FIRST LAUNCH, THE CRANIAL APPLICATION DID NOT START. THE APPLICATION UPDATE TO VERSION 3.1.5 WAS SUCCESSFUL, AND ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) CONFIGURATION WAS OK. AFTER ABOUT AN HOUR OF WORK, THE MONITOR BEGAN TO RESTART BY ITSELF. AFTER SOME TIME, IT SEEMED AS IF IT WAS NOT RECEIVING AN INPUT SIGNAL FROM THE GRAPHICS CARD. WHEN LEAVING THE HOSPITAL, THERE WAS NO IMAGE ON THE MONITOR, AND THE COMPUTER DID NOT START AND RESTARTED BY ITSELF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744232 ↗
• MalfunctionFeb 7, 2025Application Program Problem; Communication or Transmission Problem; Application Program Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE DOCTOR TRIED TO IMPORT IMAGES FOR DEEP BRAIN STIMULATION (DBS) THE SYSTEM DISPLAYED AN ERROR CODE 721 "CANNOT NEGOTIATE WITH QR SERVER", AND WHEN HE TRIED TO EXPORT IMAGES THE EXPORT FAILED. WHILE TROUBLESHOOTING THE ISSUE SEEMED TO RESOLVE, AT LEAST FOR IMPORTING IMAGES. IT COULD NOT BE VERIFIED WHETHER THE EXPORTING WAS RESOLVED. THE PROBABLE CAUSE OF THE ERROR 721 COULD BE A RESULT OF PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS) BEING DOWN, OR AN INCORRECT AE TITLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338265 ↗
• MalfunctionJul 3, 2024Application Program Problem; Application Program Freezes or Fails to Launch; Application Program Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM RECEIVED AN ERROR MESSAGE, "THE SYSTEM IS RUNNING IN LOW-GRAPHICS MODE," ALONG WITH THE UBUNTU GRUB MENU APPEARING. THE MESSAGE APPEARED THREE TIMES AND HAD NOT APPEARED AGAIN SINCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668389 ↗
• MalfunctionJul 6, 2021Display or Visual Feedback Problem; Human-Device Interface Problem; Display or Visual Feedback Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SCREEN OF THE NAVIGATION SYSTEM WAS BLUE WITHIN ORTHOGONAL VIEWS. IT WAS NOTED THAT, WHILE IN THE PLANNING PORTION OF THE APPLICATION SOFTWARE, THE MONITOR PICTURE WAS A BLUE SCREEN INSTEAD OF EXAM INFORMATION WHICH WAS EXPECTED TO DISPLAY THE TRAJECTORY VIEWS, CORONAL, AXIAL OR SAGITTAL VIEWS. IT WAS REPORTED THAT THE APPLICATION MENU WAS VISIBLE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122176 ↗
• MalfunctionJun 14, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PLANNING STATION SYSTEM WAS NOT BOOTING UP. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995034 ↗
• MalfunctionJun 2, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATED THE REPORTED ISSUE COULD NOT BE REPLICATED WHEN THEY ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11920992 ↗
• MalfunctionMay 24, 2021Computer Software Problem; Application Program Freezes or Fails to Launch; Computer Software Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE COMPUTER WOULD NOT START THE CRANIAL SOFTWARE. THERE WAS A FAILURE IN SR MANAGER THAT WAS UNRECOVERABLE. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11869958 ↗
• MalfunctionMar 30, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE APPLICATION SOFTWARE WOULD NOT BOOT ON THE PLANNING SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE CORRECT EVENT DATE IS (B)(6) 2020, NOT (B)(6) 2020. THE EVENT DESCRIPTION HAS BEEN UPDATED TO REFLECT THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11589281 ↗
• MalfunctionMar 5, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLANNING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE PLANNING SYSTEM WOULD NOT BOOT. IT WAS REPORTED THAT THE SYSTEM BOOTED TO A "BOOT DISC ERROR" MESSAGE AND WOULD NOT PROGRESS PAST THE PROMPT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423026 ↗
• MalfunctionFeb 12, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLANNING SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS UNRESPONSIVE AND STACKED WHEN USING THE STEALTHVIZ APPLICATION SOFTWARE. IT WAS REPORTED THAT THE NAVIGATION SYSTEM RESTARTED AND WAS UNRESPONSIVE DURING THE SESSIONS/ ADDITIONALLY,. IT WAS REPORTED THAT THE USER WAS UNABLE TO TURN ON "STATISTICS MODE" IN THE APPLICATION SOFTWARE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11321627 ↗
• MalfunctionFeb 1, 2021Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PLANNING SYSTEM BEING USED PRIOR TO A CRANIAL RESECTION. IT WAS REPORTED THAT THE DTI EXAMS COULD NOT BE TRANSFERRED OVER DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM). THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259398 ↗
• MalfunctionJan 20, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS NOT A PROBLEM WITH THE MONITOR, BUT WITH THE PLANNING COMPUTER. WITH THIS WE HAD TO REPLACE THE ENTIRE PLANNING (MONITOR INCLUDED), AS SUGGESTED BY THE MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11202178 ↗
• MalfunctionJan 8, 2021Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM HAD NO RESPONSE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139093 ↗
• MalfunctionAug 20, 2020Communication or Transmission Problem; Application Program Freezes or Fails to Launch; Communication or Transmission Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED. THE ISSUE WAS NOTED TO BE CAUSED BY AN ISSUE WITH THE SITES PACS NETWORK.

  Patient problems: No Patient Involvement

  MAUDE report 10431466 ↗

Other Medtronic Navigation, Inc. products

• O-ARM17 models · 9,235 reports · 5 recalls
• StealthStation S8 Platform14 models · 8,402 reports
• Stealthstation S711 models · 5,756 reports
• StealthStation S86 models · 2,235 reports
• Fusion ENT Image Guidance System5 models · 2,033 reports
• Visualase25 models · 625 reports · 3 recalls
• NavLock9 models · 134 reports · 1 recall
• AxiEM12 models · 62 reports · 2 recalls