StealthStation S8 Platform 9735665 (UDI 00763000359898)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00763000359898), received between Jun 10, 2022 and Jun 29, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K162309); they may or may not involve this specific model.

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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TOUCH SCREEN WAS FLICKERING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25653794 ↗
• MalfunctionApr 16, 2026Display or Visual Feedback Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE HEADS-UP DISPLAY (HUD) SCREEN SHOWED ABNORMALLY WHEN THE NAVIGATION SYSTEM WAS CONNECTED TO THE MICROSCOPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904235 ↗
• MalfunctionFeb 3, 2026Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS INACCURATE POSITIONING BEFORE AND AFTER REGISTRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24245512 ↗
• MalfunctionDec 31, 2025Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO CONNECT TO AN ACTIVE TOOL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934041 ↗
• MalfunctionMar 28, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT A ¿LOCALIZER NOT CONNECTED¿ MESSAGE WAS DISPLAYED WHEN REPOSITIONING THE CAMERA ARM. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724032 ↗
• MalfunctionMar 28, 2025Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING A "LOCALIZER NOT CONNECTED" MESSAGE. THE MANUFACTURER REPRESENTATIVE STATED THAT THEY MOVED THE CAMERA ARM AROUND AND THE MESSAGE WENT AWAY. IT WAS NOTED THAT THE CASE PROCEEDED WITHOUT ISSUE. THERE WAS NO DELAY TO THE PROCEDURE AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724013 ↗
• MalfunctionMar 24, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE INACCURACY OCCURRED FOLLOWING THE IMAGING SPIN. THE INSTRUMENTS SHOWING ON THE NAVIGATION SYSTEM WERE NOT CONSISTENT WITH THE PHYSICAL LOCATION ON THE PATIENT¿S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676241 ↗
• MalfunctionJan 13, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE WAS UNABLE TO DISPLAY A SPINE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21141437 ↗
• MalfunctionDec 30, 2024Display or Visual Feedback Problem; Power Problem; Display or Visual Feedback Problem; Power Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA CART SCREEN WAS FLICKERING AND THERE WAS A DAMAGED UNINTERRUPTIBLE POWER SUPPLY (UPS) BATTERY. NO PATIENT WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036077 ↗
• MalfunctionOct 21, 2024Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS HAVING TROUBLE TO COMMUNICATE WITH ELECTRONIC PICTURE ARCHIVING AND COMMUNICATION SYSTEMS (PACS). THE MANUFACTURING REPRESENTATIVE (REP) NOTED GREEN CONFIG, GREEN PING AND RED PACS PORT IN DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM). THE REP PINGED THE PACS NETWORK, 0% PACKET LOSS. THE REP THEN PINGED 8.8.8.8, 100% PACKET LOSS. THE REP THEN CONFIRMED IP ADDRESS, AE TITLE AND PORT MATCHED WHAT PACS HAD ON THEIR END. IT WAS ALSO CONFIRMED THAT PACS WAS UNABLE TO PUSH IMAGE TO THE NAVIGATION SYSTEM. THE REP WAS UNABLE TO SEARCH FOR ANY IMAGES IN THE NETWORK TAB. IT WAS CONFIRMED PORT WAS ACTIVE, RADIOLOGY USES SAME PORT TO ACCESS PACS. THE PROBABLE CAUSE WAS A PACS PERMISSIONS ISSUE. SYSTEM ABLE TO PING PACS NETWORK BUT UNABLE TO VIEW OR PULL IMAGES. THERE WAS NO PATIENT INVOLVEMENT.THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494147 ↗
• MalfunctionSep 26, 2024Failure to Power Up; Use of Device Problem; Application Program Problem; Unexpected Shutdown; Application Program Freezes or Fails to Launch; Failure to Power Up; Use of Device Problem; Application Program 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 THE SYSTEM COULD NOT BOOT UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309176 ↗
• MalfunctionSep 12, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT WHEN THE MANUFACTURER REPRESENTATIVE (REP) ATTEMPTED TO INSTALL APPLICATION VERSION 2.1, THE SYSTEM DISPLAYED AN ERROR MESSAGE STATING "THIS INSTALLER IS NOT SUPPORTED ON THIS SOFTWARE". WHEN TROUBLESHOOTING THE REP CONFIRMED THE SYSTEM WAS RUNNING AND OPERATING ON SYSTEM VERSION 2.0.2. TH REP WAS INSTRUCTED TO INSTALL OPERATING SYSTEM VERSION 2.0.3 AND THEN INSTALL APPLICATION VERSION 2.1 AGAIN. IT WAS CONFIRMED THAT ALL REQUIRED SOFTWARE WAS ABLE TO BE INSTALLED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207000 ↗
• MalfunctionSep 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE EM INTERFACE BROKE DOWN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20189301 ↗
• MalfunctionSep 6, 2024Unexpected Shutdown; Application Program Freezes or Fails to Launch; Unexpected Shutdown; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRA-OPERATIVELY IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE SYSTEM POWERED DOWN DURING A PROCEDURE. THE SYSTEM WAS PLUGGED INTO WALL POWER AT THE TIME OF ISSUE OCCURRENCE. THE SITE REPORTED WHEN ATTEMPTING TO TURN THE SYSTEM BACK ON THE SYSTEM WAS NOT ABLE TO BOOT UP. PATIENT PRESENT, UNKNOWN DELAY. NO KNOWN IMPACT TO PATIENT OUTCOME. 2024-SEP-03 INTERFACE DETAILS (REP): ADDITIONAL INFORMATION WAS RECEIVED. TROUBLESHOOTING WAS PERFORMED, THE FIELD REPRESENTATIVE CALLED TO REPORT THE MAIN CART BATTERY SHOWED 100% IN SELF-TEST BUT SHUT OFF IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156206 ↗
• MalfunctionAug 22, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THAT THE SYSTEM CONTROL UNIT (SCU) OF THE DEVICE WAS GENERATING FAILURE IN COMMUNICATION WITH THE CAMERA. NO FURTHER INFORMATION AVAILABLE. PATIENT PRESENCE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039639 ↗
• MalfunctionAug 6, 2024Application Program Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SITE NOTICED A BATTERY SERVICE ERROR IN THE APPLICATION. THE SITE ATTEMPTED A HARD REBOOT, BUT THE ISSUE DID NOT RESOLVE. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921099 ↗
• MalfunctionJul 26, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE ELECTROMAGNETIC CONNECTOR WAS NOT RESPONDING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844655 ↗
• MalfunctionJul 25, 2024Mechanical Problem; Application Program Problem; Mechanical Problem; Application Program Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE CAMERA SHOWED A RED BLINKING LIGHT AND THE DISPLAY SHOWED A LOCALIZER FAULTED MESSAGE. THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) SHOWED AN ORANGE LIGHT WHEN THE EQUIPMENT WAS POWERED ON, EVEN WITH THE ETHERNET CABLE DISCONNECTED.  THE ISSUE OCCURRED AT INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19826234 ↗
• MalfunctionMay 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT THE SITE WERE LOSING ACCURACY. STRAIGHT SUCTION EXPLORING SKULL BASE IN FNOIDS MEDIALLY AND LATERALLY. IT WOULD COME AND GO. STRAIGHT SUCTION WOULD STAY PLUGGED IN AND THE DOCTOR WOULD PUT IT TO THE SIDE AND THEN WHEN BRINGING IT BACK INTO THE FIELD THEY WOULD HAVE TO REVERIFY. THE SECOND STRAIGHT SUCTION THAT THEY USED WAS ALSO HAVING A HARD TIME VERIFYING. THE MANUFACTURER REPRESENTATIVE NOTICED METAL RAILS UNDERNEATH THE BED NEAR THE BED. THIS OCCURRED INTRAOPERATIVELY, AND THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383308 ↗
• MalfunctionMay 21, 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 SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE EXPERIENCED AN ALLEGED INACCURACY WHILE IN SURGERY. THEY HAD PREVIOUSLY TAKEN A SPIN THAT THEY WERE CONFIDENT IN BUT AFTER TAKING A SECOND, THE SURGEON FELT OFF BY AN UNKNOWN DISTANCE AND DIRECTION. THEY TOOK A THIRD SPIN IN ATTEMPT TO RESOLVE BUT STILL FELT INACCURATE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF 2 HOURS DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367663 ↗
• MalfunctionOct 31, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITOR POWER CABLE COLLET WAS NOT FUNCTIONAL AND THE MEDTRONIC REPRESENTATIVE (REP) WAS HAVING TROUBLE INSERTING IT INTO THE PORT OF THE MONITOR. THE REP WOULD TRY TO USE THE CORD OF A SECOND SYSTEM TO SEE IF IT WOULD INSERT AND CALL BACK. THIS WAS NOTICED UPON INSTALLATION. NO PATIENT WAS PRESENT. THE REP CALLED TO REPORT TROUBLESHOOTING ON THIS SYSTEM. THE REP SWAPPED MONITORS BETWEEN A KNOWN FULLY FUNCTIONAL SYSTEM AND THE SYSTEM EXPERIENCING THE REPORTED ISSUE. THE ISSUE BEGAN TO OCCUR ON FULLY FUNCTIONAL SYSTEM ONCE MONITORS COMPLETED SWAP AND ISSUE STOPPED ON THIS SERIAL NUMBER. THE REP REPORTED THAT UPON DOING THE SWITCH THE DC IN PORT ON THE BAD MONITOR COULD NOT BE PROPERLY SEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18041797 ↗
• MalfunctionAug 17, 2023Application Program Freezes or Fails to Launch; 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 SITE WAS HAVING ISSUES WITH THE LOCALIZER FAULTING WHEN ENTERING THE APPLICATION. THE MANUFACTURER REPRESENTATIVE GRABBED ANOTHER EMITTER FROM A KNOWN WORKING SYSTEM, AND IT FUNCTIONED AS INTENDED. THE MANUFACTURER REPRESENTATIVE USED A FAULTY EMITTER ON ANOTHER SYSTEM AND IT STILL FAULTED. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THEY WERE ABLE TO ISOLATE ISSUE TO EM EMITTER USING SECOND NAVIGATION SYSTEM /EM EQUIPMENT TO TRIAL COMPONENTS. ADDITIONAL INFORMATION WAS RECEIVED. THE MANUFACTURER REPRESENTATIVE FOUND THE SYSTEM DISPLAYED LOCALIZER ERROR WHEN STAFF SETUP THE NAVIGATION SYSTEM FOR A ELECTROMAGNETIC (EM) PROCEDURE. THE MOST LIKELY / SUSPECTED CAUSE OF THE ISSUE WAS THE ELECTROMAGNETIC EMITTER BOX NOT FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564430 ↗
• MalfunctionAug 3, 2023Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THERE WERE DIFFICULTIES REGISTERING THE PATIENT. THE SURGEON ATTEMPTED THREE-POINT TOUCH, BUT THE SECOND POINT POPULATED WAY ON THE PATIENT'S LEFT WHEN IT SHOULD HAVE JUST BEEN SUPERIOR TO THE NOSE. THE THIRD POINT POPULATED ON THE PATIENT'S CHEEK. THE MANUFACTURER REPRESENTATIVE (REP) DID STATE THAT THE SITE HAD A MERGED EXAM THAT CONTAINED THE PATIENT'S NECK AND CHEST. THE REP RECOMMENDED CROPPING THE EXAM SO IT WAS MORE TO PROTOCOL, BUT THERE WERE STILL REGISTRATION DIFFICULTIES. THE REP INSTRUCTED THE SITE TO SWITCH TO A MINIMUM TRACE BASED REGISTRATION. THE SITE CONTINUED TO FAIL SEVERAL TIMES. THE SURGEON PASSED IT ONCE, BUT IT WAS OVER 2 CM INACCURATE WHEN NAVIGATING TO KNOWN ANATOMICAL LANDMARKS. THERE WAS A LESS THAN ONE HOUR PROCEDURE DELAY BEFORE THE SURGEON ABORTED THE USE OF THE NAVIGATION SYSTEM AND CANCELLED THE CASE. THE PROCEDURE WAS ABORTED AFTER ANESTHESIA HAD BEEN ADMINISTERED, BUT PRIOR TO AN INCISION BEING MADE. THE PROCEDURE WAS RESCHEDULED FOR A LATER DATE, BUT THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452441 ↗
• MalfunctionJul 11, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT INTRAOPERATIVELY, THE SITE WAS UNABLE TO TRACK ANY INSTRUMENTS OR REFERENCE FRAMES. THERE WAS NO IMPACT ON PATIENT OUTCOME AND THE ISSUE CAUSED A LESS THAN 1 HOUR DELAY. THE NDI TOOLBOX WAS CHECKED FOR TROUBLESHOOTING AND IT WAS ALL GREEN. THE INSTRUMENT WAS ABLE TO TRACK OUTSIDE OF THE OPERATING ROOM (OR). THE ISSUE WAS UNABLE TO BE DUPLICATED OUTSIDE OF THE OR. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT TROUBLESHOOTING WAS DONE TO RESOLVE THE ISSUE. THE TROUBLESHOOTING INCLUDED, CLEANING AND REPLACING THE SPHERES. THE SITE MADE SURE THAT THERE WAS NOTHING BLOCKING THE FRAME AND THE LIGHTS ON THE BOOM WERE REMOVED AWAY FROM THE SPHERES. DIFFERENT INSTRUMENTS WERE TRIED AND THE INSTRUMENTS WERE BOTH UNVERIFIED AND RE-VERIFIED. IT WAS DISCOVERED THAT THE SURGEON'S HEADLAMP WAS CAUSING THE SPHERES TO BE BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297661 ↗
• MalfunctionJun 29, 2023Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT AN OUT OF TERRITORY SURGEON ASKED IF A SURGEON HEADLAMP COULD CAUSE A POSSIBLE ISSUE WITH TRACKING. THE SURGEON REPORTED THAT IF THE LIGHT WAS AIMED AT THE REFERENCE FRAME, THEN THE REFERENCE FRAME COULD NOT BE TRACKED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225180 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162309. One submission often covers many models, so check the product and lot details in each record.

• Z-1776-2024 · Mar 26, 2024 · Open, Classified
  Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutane
• Z-1995-2020 · Aug 9, 2019 · Terminated
  Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS Licen