Mirage 103-0608Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000294120), received between Nov 25, 2020 and Aug 13, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE MIRAGE .008 GUIDEWIRE RUPTURED INSIDE THE PATIENT. IT WAS REPORTED THAT THE MIRAGE .008 GUIDEWIRE FAILED AND RUPTURED INSIDE THE PATIENT. REMOVAL OF THE BROKEN GUIDEWIRE SEGMENT WAS A TTEMPTED BUT IT COULD NOT BE REMOVED COMPLETELY. HOWEVER, THIS DID NOT CAUSE COLLATERAL DAMAGE TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22797934 ↗
• MalfunctionMay 1, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT DURING THE SURGERY, THE MIRAGE GUIDEWIRE WAS FOUND TO BE KINK AND WAS USED SMOOTHLY AFTER REPLACEMENT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED VESSEL TORTUOSITY WAS NORMAL. THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943540 ↗
• MalfunctionOct 14, 2024Break; Difficult or Delayed Activation; Break; Difficult or Delayed Activation

  MEDTRONIC RECEIVED A REPORT THAT THE MIRAGE GUIDEWIRE HAD DIFFICULT NAVIGATION AND A THREADY WIRE WAS FOUND AT THE TIP. IT WAS REPORTED THAT THE OPERATOR CROSSED THE FIRST BEND AT THE ORIGIN OF RIGHT M2 SEGMENT, THEN AFTER 1 CM AGAIN THERE WAS ACUTE BEND WHICH WAS CROSSED BY THE MIRAGE AND MARATHON CATHETER. AT THE NEXT BEND OF THE M3 JUNCTION, THE MIRAGE DIDN'T CROSS. THE OPERATOR ATTEMPTED 3-4 TIMES BUT IT WAS NO USE. AT ONE POINT THE MIRAGE WAS STUCK IN THE M3 JUNCTION, AND THE OPERATOR TOOK OUT THE MIRAGE AND MARATHON FROM THE SYSTEM. THEY NOTICED THERE WAS A THREADY WIRE ON THE MIRAGE AT THE TIP. THE DEVICE WAS KEPT ASIDE, AND A NEW MIRAGE WAS USED TO FINISH THE CASE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20447874 ↗
• InjuryMar 7, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  MEDTRONIC RECEIVED INFORMATION REGARDING A MIRAGE GUIDEWIRE THAT HAD DIFFICULTY NAVIGATING THE MARATHON CATHETER TO THE INTENDED LOCATION AND CATHETER OCCLUSION THAT OCCURRED IN THE SAME CASE. THE PATIENT WAS UNDERGOING A PROCEDURE FOR GLUE TREATMENT OF A DURAL ARTERIOVENOUS FISTULA VIA MIDDLE MENINGEAL ARTERY ACCESS. VESSEL TORTUOSITY WAS SEVERE. ACCESS VESSEL DIAMETER WAS 1.65MM. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. FIRST, IT WAS ATTEMPTED TO NAVIGATE THE MARATHON CATHETER TO THE TREATMENT LOCATION ALONG A MIRAGE GUIDEWIRE. HOWEVER, THE MARATHON WAS NOT ABLE TO NAVIGATE ON THE MIRAGE. THE MIRAGE GUIDEWIRE WAS REMOVED AND REPLACED WITH A HYBRID 010 WIRE WHICH WAS USED SUCCESSFULLY WITH THE MARATHON CATHETER. THE CATHETER REACHED THE TARGET SITE AND WAS FLUSHED FIRST WITH SALINE, FOLLOWED BY 5% DEXTROSE. THE GLUE INJECTION WAS STARTED BUT THE GLUE DID NOT COME OUT THE DISTAL END OF THE CATHETER; THERE WAS RESISTANCE AND THE CATHETER WAS CLOGGED. THERE WERE NO ASSOCIATED PATIENT SYMPTOMS AND NO INJURY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CASE WAS ABANDONED. THE MIRAGE WIRE LOST ITS SHAPE DUE TO ARTERY TORTUOSITY, NO DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16495053 ↗
• MalfunctionAug 30, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE MIRAGE GUIDEWIRE BROKE INTO 2 PIECES INSIDE THE CATHETER. THE GUIDEWIRE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321961 ↗
• MalfunctionAug 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A MIRAGE GUIDEWIRE WAS STUCK IN A MARATHON CATHETER. PHYSICIAN WAS TREATING A RUPTURED ARTERIOVENOUS MALFORMATION (AVM) CASE IN WHICH ONYX EMBOLIZATION WAS PLANNED. MAIN FEEDER WAS FROM LEFT ANTERIOR CEREBRAL ARTERY (ACA), PHYSICIAN TOOK THIS MARATHON OVER MIRAGE AND REACHED INSIDE THE AVM NIDUS. WHILE TAKING OUT THIS MIRAGE, IT WAS NOT COMING OUT OF MARATHON. SO PHYSICIAN HAD TO TAKE OUT BOTH OF THESE MARATHON & MIRAGE, THEN HE TOOK NEW MARATHON & MIRAGE AND COMPLETED THE PROCEDURE WITH ONYX EMBOLIZATION. THE CATHETER WAS FLUSHED AS PER INSTRUCTIONS FOR USE (IFU).  THE ACCESS VESSEL WAS THE LEFT ACA WITH A DIAMETER OF 2.4MM. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE GUIDEWIRE WAS ABLE TO PASS THE CATHETER HUB. THERE WAS NO DAMAGE FOUND TO THE CATHETER. THE GUIDEWIRE TIP WAS SHAPED. THERE WAS NO KINK OR DAMAGE FOUND ON THE GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15274917 ↗
• MalfunctionMay 9, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE MIRAGE GUIDEWIRE TIP BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN INTRACRANIAL ARTERIOVENOUS MALFORMATION (AVM). THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WHICH WAS 8MM IN DIAMETER. IT WAS REPORTED THAT MIRAGE GUIDEWIRE WAS PLACED IN THE BLOOD VESSELS AND ROTATED FOR ABOUT 2 TURNS BEFORE THE TIP OF THE GUIDEWIRE BROKE AND ESCAPED. A SOLITAIRE AB WAS USED TO CAPTURE AND SUCCESSFULLY REMOVE THE BROKEN GUIDEWIRE SEGMENT. THE SURGEON WAS ASKED TO ESTIMATE THE LENGTH OF THE BROKEN TIP, AND IT WAS SAID THAT THEY THOUGHT IT TO BE THE SHORT PART OF THE TIP. THE SURGEON NOTED THAT IN THE SAME SURGICAL PROCEDURE AND POSITION MULTIPLE GUIDEWIRES HAD BEEN ROTATED MANY TIMES BUT THIS BREAKAGE HAD NOT OCCURRED. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A MARATHON CATHETER AND A REBAR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337856 ↗
• MalfunctionSep 29, 2021Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ISSUES NOTED DURING THE PROCEDURE WHICH RESULTED IN THE GUIDEWIRE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547407 ↗
• MalfunctionAug 2, 2021Material Integrity Problem; Material Integrity Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. IT WAS REPORTED THAT THE GUIDEWIRE WAS PREPARED AND HYDRATED PER THE IFU. THERE WAS NO DAMAGE FOUND TO THE CATHETER HUB. THE GUIDEWIRE TIP NOT PREFORMED, IT WAS A MAGIC 1.5 FR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260224 ↗
• MalfunctionJul 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE SURGEON BROKE THE TIP OFF OF THE MIRAGE GUIDEWIRE IN THE MENINGEAL BRANCH ON THE DURAL ARTERIOVENOUS FISTULAS ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229233 ↗
• MalfunctionJul 1, 2021Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WERE RIGID, PLASTIC THREADS ADHERED TO THE MIRAGE GUIDEWIRE AFTER REMOVAL FROM THE MARATHON MICROCATHETER. THE PATIENT WAS UNDERGOING DIAGNOSTIC TREATMENT. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN PERFORMING THE DIAGNOSTIC PROCEDURE AND INSERTING THE MIRAGE GUIDE INTO THE MARATHON MICROCATHETER, IT NAVIGATED PERFECTLY AND ACHIEVED THE TARGET. HOWEVER, WHEN THE GUIDEWIRE WAS REMOVED, IT WAS OBSERVED THAT PIECES OF THREAD ADHERED TO THE GUIDEWIRE. AT FIRST, IT WAS THOUGHT TO BE PART OF A GAUZE, AND THE GUIDEWIRE WAS RE-INSERTED IN THE MICROCATHETER TO CONTINUE THE PROCEDURE. WHEN THE WIRE WAS REMOVED TO FINISH THE PROCEDURE, MORE OF THESE THREADS WERE OBSERVED. WHEN TOUCHED, IT WAS NOTED THE THREADS WERE RIGID AND LOOKED LIKE PLASTIC DETACHED FROM THE GUIDEWIRE. NO MATERIAL SUCH AS ONYX, DMSO, OR CONTRAST WERE USED, ONLY NACL 0.9%. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A LONG SHEATH, MARATHON MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100355 ↗
• MalfunctionNov 25, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO ISSUES WITH THE MIRAGE OR APOLLO PRIOR TO THE BREAK. THE WIRE WAS SHAPED AS IT WAS NORMALLY BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10899457 ↗