N/A 960-539 (UDI 00681490991520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00681490991520), received between Sep 27, 2016 and Apr 29, 2026 — classified as 1 death, 46 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (14 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LOCKING SCREW ON THE BIOPSY GUIDE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034150 ↗
• MalfunctionFeb 5, 2026Activation, Positioning or Separation Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE BIOPSY GUIDE WAS NOT FUNCTIONAL AND WOULD NOT STAY IN PLACE DURING A CASE. THE MANUFACTURER REPRESENTATIVE (REP) STATED THE BIOPSY GUIDE WAS USED DURING THE CASE. THIS ISSUE CAUSED AN UNKNOWN SURGICAL DELAY. THE IMPACT ON THE PATIENT'S OUTCOME WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270046 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM OUTSIDE OF PROCEDURE. IT WAS REPORTED THE CERVICAL PROBE ACCURACY COULD NOT BE ACHIEVED. THE BIOPSY GUIDE WOULD MOVE, EVEN WHEN IT WAS LOCKED. THERE WAS A FOREIGN OBJECT IN THE HOLLOW OF THE SOLERA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222365 ↗
• DeathNov 3, 2023Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT ONE SCREW OF THE BIOPSY NEEDLE KIT WAS BROKEN. WHILE PERFORMING A TEMPORAL BIOPSY OF A DIFFUSED BRAIN LESION UNDER NEURO-NAVIGATION, THE SURGEON ATTACHED THE INSTRUMENT HOLDER ON THE SUPPORT ARM. AFTER BLOCKING THE TRAJECTORY, THE SURGEON MADE A DRILL BIT HOLE. THE SURGEON NOTICED THAT THE INSTRUMENT HOLDER HAD MOVED. WHEN THE BIOPSY NEEDLE WAS INSERTED, IT DID NOT ENTER THE DRILL HOLE CONFIRMING THAT THE INSTRUMENT HOLDER HAD MOVED. THE SURGEON RECALCULATED A NEW TRAJECTORY. AT THIS POINT, THE SURGEON NOTICED THAT THE INSTRUMENT HOLDER WAS NOT HOLDING PROPERLY. IT WAS NOT POSSIBLE FOR THE SURGEON TO TIGHTEN IT FURTHER SO THAT IT WOULD NO LONGER MOVE ON ONE OF ITS ROTATIONAL AXES (THE PROXIMAL AXIS.) THE SURGEON BLOCKED IT WITH ADHESIVE TAPE TO BE ABLE TO VALIDATE A NEW TRAJECTORY. IT WAS THUS NO LONGER MOBILE. THE SURGEON WAS ABLE TO MAKE A SECOND DRILL HOLE AND INSERT THE BIOPSY NEEDLE. ON NEURO-NAVIGATION, THE NEEDLE'S PROGRESS WAS CORRECTLY SEEN UP TO, BUT NOT BEYOND, THE CHOSEN TARGET. DURING THE BIOPSY, THE PATIENT EXPERIENCED TACHYCARDIA AND A HYPER

  Patient problems: Blurred Vision; Hemorrhage/Blood Loss/Bleeding; High Blood Pressure/ Hypertension; Tachycardia

  MAUDE report 18067098 ↗
• MalfunctionJul 25, 2022Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A CRANIAL RESECTION. IT WAS REPORTED THAT THE PAD WAS NOT TIGHTENING PROPERLY AND HOLDING. THE SURGEON WAS ABLE TO FINISH CASE. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15092933 ↗
• MalfunctionJul 20, 2022Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED INTRAOPERATIVELY DURING A CRANIAL RESECTION. IT WAS REPORTED THAT THE PRECISION AIMING DEVICE (PAD) WAS NOT TIGHTENING. THE SURGEON USED THEIR OTHER PAD FOR THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065414 ↗
• MalfunctionJun 10, 2022Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE BIOPSY GUIDE WAS DEFECTIVE. IT WAS NOTED THAT THE BIOPSY NEEDLE DEPTH STOP SCREW COULD NOT BE TIGHTENED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653697 ↗
• MalfunctionApr 26, 2022Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A BIOPSY. IT WAS REPORTED THAT THE SCREW OF THE BIOPSY GUIDE STOPPED TURNING. IT WAS ALSO REPORTED THAT THE CAMERA ARM WAS NOT FIXED AND WOULD COME DOWN. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH CONTINUOUS USE OF THE NAVIGATION SYSTEM. THERE WAS A DELAY OF LESS THAN ONE HOUR AND NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209749 ↗
• MalfunctionAug 4, 2021Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE VERTEK BIOPSY PRECISION AIMING DEVICE WOULD NOT LOCK PROPERLY. THE LOCKING MECHANISM RESPONSIBLE FOR GROSS MOVEMENTS WOULD NOT LOCK. A SECOND VERTEK BIOPSY SET WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274126 ↗
• MalfunctionMar 5, 2021Material Integrity Problem; Output Problem; Material Integrity Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE GUIDE BIOPSY WAS DEFECTIVE. NO PATIENT INVOLVEMENT WAS REPORTED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE BIOPSY NEEDLE WOULD NOT LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11425322 ↗
• MalfunctionMay 28, 2020Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR AN ELECTRODE AND PROBE PLACEMENT. IT WAS REPORTED THAT THE AFTER THE SURGEON HAD TIGHTENED THE SCREW THE GUIDANCE TOOL MOVED. EVEN IF TIGHTENED REALLY HARD. THERE WAS NO REPORTED DELAY AND NO REPORT IMPACT TO PATIENT OUTCOME. THE SITE SWITCHED TO A DIFFERENT GUIDE TOOL TO PROCEED WITH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10097255 ↗
• MalfunctionApr 8, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING A CLINICAL CASE THE SITE WAS HAVING ISSUES WITH THE PAD AS IT WAS NOTED THE SECOND WINGNUT ON THE DEVICE WAS TO HARD TO TURN AND TIGHTEN. THE SITE HAD TO USE A LARGE AMOUNT OF FORCE UNTIL IT WAS ABLE TO BE USED. THE CLINICAL SPECIALIST IS REQUESTING A QUOTE FOR REPLACEMENT. PATIENT WAS PRESENT. THERE WAS A LESS THAN 5 MIN DELAY NOTED IN THE CASE. NEW INFORMATION RECEIVED: THE TYPE OF SURGICAL PROCEDURE IS CRANIAL BIOPSY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9940719 ↗
• MalfunctionFeb 11, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE LOCK SCREW WAS BROKEN ON THE BIOPSY GUIDE. NO PATIENT WAS PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9694464 ↗
• MalfunctionNov 20, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE PRECISION AIMING DEVICE (PAD) WAS NOT TIGHTENING. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 9348154 ↗
• MalfunctionSep 19, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY. IT WAS REPORTED THAT WHEN THE SITE WAS TRYING TO TIGHTEN THE PRECISION AIMING DEVICE (PAD) IT WOULD NOT TIGHTEN ALL THE WAY. THEY USED ANOTHER PAD THAT WAS ON SITE TO COMPLETE THE CASE. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9091215 ↗
• MalfunctionAug 2, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A CRANIAL BIOPSIES, THE SCREW ON THE PRECISION AIMING DEVICE (PAD) OF THE BIOPSY KIT WERE NOT LOCKING. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8857219 ↗
• MalfunctionJun 17, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED OUTSIDE OF A PROCEDURE THAT THE BIOPSY PART WAS DAMAGED AND COULD NOT ENGAGE NEEDLE. NO PATIENT WAS PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 8704417 ↗
• MalfunctionApr 22, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE BIOPSY GUIDE WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8536158 ↗
• MalfunctionApr 16, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED BY CENTRAL STERILIZATION AT THE SITE THAT THE PRECISION AIMING DEVICE WAS NOT WORKING PROPERLY. IT WAS SUSPECTED THAT IT WAS NOT TIGHTENING DOWN PROPERLY. THE ISSUE WAS FIRST IDENTIFIED DURING AN ELECTRODE AND LEAD PLACEMENT PROCEDURE. THE SITE USED ANOTHER PRECISION AIMING DEVICE FOR THE CASE. THERE WAS A VERY SHORT DELAY TO THE PROCEDURE (LESS THAN ONE HOUR). THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. UPDATE: THE SITE STATED THAT THEY WILL NOT BE ORDERING A NEW ONE AT THIS TIME AS THEY HAVE CHOSEN TO HAVE THEIR CURRENT PART FIXED BY THIRD-PARTY. WE INFORMED THEM THAT THIS WAS NOT RECOMMENDED BUT IT IS ULTIMATELY THEIR DECISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8517648 ↗
• MalfunctionDec 27, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE PRECISION AIMING DEVICE (PAD) DEVICE WOULD NOT FULLY LOCK DURING A CASE. THERE WAS NO PATIENT IMPACT REPORTED AND NO DELAY TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8200408 ↗
• MalfunctionDec 1, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SCREW OF THE BIOPSY GUIDE WAS DIFFICULT TO TIGHTEN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 8122497 ↗
• MalfunctionMar 15, 2018Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE SCREWS ON THE PRECISION AIMING DEVICE WERE STRIPPED. THE REPORTED ISSUE WAS DISCOVERED DURING STERILIZATION. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7342409 ↗
• MalfunctionNov 28, 2017Mechanical Problem; Mechanical Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE OUTSIDE OF PROCEDURE, THE PRECISION AIMING DEVICE (PAD) WOULD NOT FULLY TIGHTEN THOUGH THE SCREW OF THE GUIDE WAS TIGHTENED. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ISSUE.

  Patient problems: No Patient Involvement

  MAUDE report 7064194 ↗
• MalfunctionNov 21, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL BIOPSY, THE BIOPSY GUIDE COULD NOT BE TIGHTENED SUFFICIENTLY. IT WAS REPORTED THAT THE SCREW WOULD MOVE WHEN MINIMAL FORCE WAS APPLIED. THE SITE ELECTED TO COMPLETE THE PROCEDURE WITH THE BIOPSY GUIDE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7049827 ↗
• MalfunctionOct 26, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE BIOPSY GUIDE'S THUMB SCREW WAS STRIPPED AND COULD NOT HOLD THE RETENTION TUBE OR PROBE IN PLACE. THE SCREW WAS NOTED TO BE UNABLE TO TIGHTEN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6982033 ↗