ONYX 18Recalls & reported problems across all models

We found 2 models of ONYX 18 by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jun 2, 2017 and Jan 14, 2026 — classified as 1 death, 34 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (13 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. 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

Most reported ONYX 18 problems

ONYX 18 models

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

• ONYX 18 105-7100-060

  Agent, injectable, embolic
  1 death43 reports
• Onyx 18 105-7100-060

  Agent, injectable, embolic
  15 reports

Recent ONYX 18 adverse event reports

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

• MalfunctionJan 14, 2026Migration or Expulsion of Device; Premature Activation; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT IS CURRENTLY ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069054 ↗
• InjuryDec 10, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Material Deformation; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE, MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS LEFT M4 OCCLUSION. IT WAS REPORTED THAT WHEN DRAWING UP DMSO INTO THE SYRINGE PROVIDED IN THE ONYX KIT, THE LUER-LOCKED SYRINGE WAS ATTACHED TO THE DUO 167 MICROCATHETER, INFUSED DMSO AS USUAL. UPON REMOVING THE DMSO SYRINGE, THE INNER TIP OF THE SYRINGE BROKE OFF AND REMAINED IN THE MICROCATHETER HUB. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED. MEDWATCH REPORT (MW5178827) PROVIDED CLARIFICATION OF EVENT DETAILS. IT WAS REPORTED THAT THE ONYX 18 KIT DSMO SYRINGE WAS ATTACHED TO A NON-MEDTRONIC MICROCATHETER, DSMO WAS INJECTED, AND THE DSMO SYRINGE WAS REMOVED. THE ONYX SYRINGE WAS ATTACHED TO THE MICROCATHETER AND RESISTANCE WAS MET DURING AN ATTEMPT TO INJECT ONYX 18 LIQUID EMBOLIC. THE DSMO SYRINGE WAS INSPECTED AND FOUND THAT THE TIP OF THE SYRINGE WAS MISSING AND HAD REMA

  Patient problems: Ischemia; Ischemia Stroke; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 23770541 ↗
• MalfunctionJun 11, 2025Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT THAT THE MARATHON CATHETER ENCOUNTERED RESISTANCE AT THE DISTAL SECTION AND BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR A SPINAL ANGIO AND EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODE RATE. THE ACCESS VESSEL WAS IN THE RIGHT GROIN WITH A 6MM DIAMETER. IT WAS REPORTED THAT THE PHYSICIAN INJECTED ONYX, AND WHEN THEY ATTEMPTED TO REMOVE THE CATHETER, THEY FELT RESISTANCE AND THE CATHETER BROKE OFF AT THE DISTAL END. A SNARE WAS USED TO RETRIEVE THE DISTAL SEGMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSE OF THE CATHETER BREAK/DIFFICULT REMOVAL WAS UNKNOWN. IT WAS HARD TO DETERMINE IF THE CATHETER WAS TRAPPED IN THE ONYX OR THE VESSEL. THERE IS AN ONYX CAST IN THE VESSEL. THE CATHETER BROKE OFF. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE ORIGINAL INTENDED PROCEDURE WAS DIAGNOSTIC SPINAL ANGIOGRAM, RIGHT T11 SPINAL ARTERIOVENOUS FISTULA ONYX 18 EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22187342 ↗
• MalfunctionApr 4, 2025Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT THAT A PROCEDURE WENT AS PLANNED. HOWEVER, WHEN THE MICROCATHETER WAS REMOVED AT THE END OF THE PROCEDURE, THE DISTAL END SNAPPED AND ABOUT 5CM WAS LEFT BEHIND IN THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER WITH A SNARE, BUT IT WAS UNSUCCESSFUL. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS ENTRAPPED/STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE BROKEN SEGMENTS REMAIN IN THE PATIENT IN THE IMAX. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR ONYX EMBOLIZATION OF MMA. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE EXTERNAL CAROTID ARTERY (ECA) - INTERNAL MAXILLARY ARTERY (IMAX) - MIDDLE MENINGEAL ARTERY (MMA) WITH A 2.5MM DIAMETER. ANCILLARY DEVICES INCLUDE AN ONYX 18 LIQUID EMBOLIC. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PROCEDURE

  Patient problems: Foreign Body In Patient

  MAUDE report 21778677 ↗
• InjuryMar 19, 2025Entrapment of Device; Migration or Expulsion of Device; Chemical Problem; Unintended Movement; Entrapment of Device; Migration or Expulsion of Device; Chemical Problem; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THE TIP AND WHAT WOULD SEEM TO BE THE LINER WAS DETACHED. THE INNER LINER IS NOT REFERRING TO THE DETACHABLE TIP. 2-4CM OF REFLUX WAS NOTED.

  Patient problems: Decreased Level of Consciousness; Foreign Body In Patient; Movement Disorder; Paresis; Perforation of Vessels; Rupture

  MAUDE report 21649267 ↗
• MalfunctionMar 11, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROCEDURE WAS COMPLETED USING ONYX AND N-BCA. THREE BOXES OF ONYX WERE USED DURING THE PROCEDURE, ALL OF THE SAME LOT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN PAUSED FOR 1 MINUTE BETWEEN INJECTIONS. THERE WAS NO ONYX REFLUX. THE DEAD SPACE OF THE DELIVERY CATHETER HAD BEEN FILLED WITH DMSO. THE AVM WAS LOCATED IN THE BRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576545 ↗
• MalfunctionNov 27, 2024Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  MEDTRONIC RECEIVED A REPORT THAT AN ONYX BECAME STUCK IN THE CATHETER (PREMATURE COAGULATION). THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). LEISION DETAILS AVM GRADE TYPE 3. THE AVM WAS LOCATED IN THE BRAIN'S FUNCTIONAL REGION (ELOQUENT AREA). THE PATIENT¿S VESSEL TORTUOSITY WAS MODERATE. WHEN AN ATTEMPT WAS MADE TO INJECT ONYX18 THROUGH THE DEFLECTOR, THE ONYX18 GOT STUCK INSIDE THE CATHETER. THE EMPTY SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THE PHYSICIAN DID NOT PAUSE DURING THE ONYX INJECTION. THE DURATION OF THE ONYX INJECTION WAS 60 SECONDS. POSTOPERATIVE FINDINGS RELATED TO BLOOD FLOW CONTRAST SHOWED NO CHANGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES: SHEATH 5 FR GLIDE SHEATH, MICROCATHETER DEFLECTOR NANO, GUIDEWIRE CHIKAI10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20796367 ↗
• MalfunctionNov 19, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A TREATMENT FOR ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION USING AN APOLLO CATHETER, THERE WAS SEVERE VESSEL TORTUOSITY IN THE PICA WITH A DIAMETER OF 1.5MM. THE PROCEDURE ENCOUNTERED RESISTANCE WHILE PASSING THE MICROWIRE, BUT IT EVENTUALLY REACHED THE DESIRED LOCATION. DURING THE INJECTION OF ONYX, THE CATHETER AUTOMATICALLY DETACHED APPROXIMATELY 15CM BEYOND THE DETACHABLE TIP, RESULTING IN CATHETER SEPARATION DUE TO ONYX ENTRAPMENT AND PART OF THE MICROCATHETER REMAINS IN THE PATIENT. SOME PART OF THE MICRO REMAINED IN THE ARTERY, AND THE CATHETER WAS BROKEN AT THE DISTAL END. ALL BROKEN SEGMENTS WERE REMOVED FROM THE PATIENT. THE INJECTION WAS CONTINUOUS WITH A WAITING TIME OF ABOUT 15-20 MINUTES, AND THERE WAS NO ONYX REFLUX. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725079 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER EMBOLIZATION WITH ONYX18, SYMPTOMS OF OTITIS MEDIA APPEARED. THE CAUSAL RELATIONSHIP WITH ONYX WAS UNKNOWN, BUT THE DOCTORS SUSPECTED IT WAS AN ALLERGIC REACTION WITH ONYX. THEY WERE MORE SUSPICIOUS OF TANTALUM POWDER RATHER THAN THE ETHYLENE VINYL ALCOHOL (EVOH) OF ONYX. THERE WERE REPORTED TO BE NO SERIOUS COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS HOSPITALIZED FOR A WEEK BUT WAS DISCHARGED. FOLLOW-UP WAS CHOSEN FOR FURTHER ACTIONS. THE OTITIS MEDIA WAS SAID TO HAVE A RECOVERY TREND, THOUGH THE CAUSE WAS NOT DETERMINED. THE PATIENT WAS UNDERGOING TREATMENT FOR A DURAL ARTERIOVENOUS FISTULA (D-AVF). THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A NON-MEDTRONIC SHEATH, GUIDE CATHETER, MICROCATHETER, GUIDEWIRE, AND COIL.

  Patient problems: Ear infection; Hypersensitivity/Allergic reaction

  MAUDE report 20566573 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED ACUTE OTITIS MEDIA. THE PATIENT HAD EAR PAIN. THE PATIENT WAS UNDER OBSERVATION AND HEADED FOR RECOVERY. ALTHOUGH THERE IS A POSSIBILITY OF AN ALLERGIC REACTION, THE EXACT CAUSE IS UNKNOWN. THE LOCATION/VESSEL OF THE ARTERIOVENOUS FISTULA WAS ORIGINATED IN THE TRANSVERSE/SIGMOID SINUS. NO OTHER SYMPTOMS WERE PRESENT. THERE WAS NO ISSUE WITH VISUALIZATION OF THE ONYX MATERIAL DURING THE PROCEDURE.

  Patient problems: Ear infection; Hypersensitivity/Allergic reaction

  MAUDE report 20566529 ↗
• MalfunctionSep 9, 2024Display or Visual Feedback Problem; Chemical Problem; Display or Visual Feedback Problem; Chemical Problem

  MEDTRONIC RECEIVED A REPORT THAT A ONYX HAD POOR VISUALIZATION AND WAS NOT COMING OUT OF THE MICROCATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A GRADE FOUR ARTERIOVENOUS MALFORMATION (AVM) IN AN ELOQUENT REGION. THE PATIENT¿S VESSEL TORTUOSITY WAS SEVERE. PHYSICIAN WAS TREATING A RUPTURED AVM WHICH WAS SUPPLIED FROM RIGHT DISTAL PCA. DUE TO TORTUOSITY AND A SMALL DIAMETER OF THE RIGHT DISTAL PCA, THEY DECIDED TO USE BALT'S SONIC 1.2F 2.5CM DETACHABLE TIP MICROCATHETER. AFTER POSITIONING THE MICROCATHETER AT THE OPTIMUM POSITION INSIDE THE NIDUS AND PRIMING IT WITH DMSO, THE PHYSICIAN STARTED TO INJECT ONYX-18. AFTER INJECTING APPX. 0.3 ML OF ONYX-18, THEY REALIZED THAT ONYX WAS NOT COMING OUT FROM MICROCATHETER AND WAS NOT VISIBLE. THE PHYSICIAN TOOK OUT THE ONYX SYRINGE AND HAD TO TAKE OUT A NEW ONYX-18 VIAL IMMEDIATELY. THE ONYX CAME OUT OF THE SONIC MICROCATHETER. THE SPEED SETTING ON THE SHAKER: 8. THE ONYX WAS MIXED FOR MORE THAN 30 MINUTES. THE ONYX VIALS DID NOT SIT MORE THAN 5 MINUTES PRIOR TO INJECTION. THE PHYSICIAN INJECTED THE ONYX IMMEDIATELY AFTER MIXING (ONYX DID NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170984 ↗
• InjuryJul 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED AN ELEVATED WHITE BLOOD CELL COUNT CONCERNING INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19807886 ↗
• InjuryJul 23, 2024No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC RECEIVED A REPORT THAT A PIPELINE PATIENT EXPERIENCED AN ELEVATED WHITE BLOOD CELL COUNT CONCERNING INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19807879 ↗
• MalfunctionJul 22, 2024Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error; Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LAB STATED, THEY MIXED UP THE VIALS. THEY TOOK MULTIPLE VIALS OUT OF THE BOX AND DID NOT PUT THEM BACK IN THE CORRECT BOXES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19797797 ↗
• MalfunctionJul 22, 2024Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error; Labelling, Instructions for Use or Training Problem; Product Quality Problem; Use of Device Problem; Expiration Date Error

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS AN ISSUE WITH THE EXPIRATION DATES IN AN ONYX KIT. THE ACCOUNT REPORTED THAT THE ONYX KIT CONTAINED A VIAL OF DMSO LOT B687507 AND ONYX 18 LOT B035828. THE ONYX LOT B035828 HAD AN EXPIRATION DATE OF 2023-06-05, WHILE THE DMSO AND TOP LEVEL ASSEMBLY HAD GOOD DATING (2027-01-31 AND 2026-11-01 RESPECTIVELY). IT WAS NOTED THE TOP LEVEL ASSEMBLY SHOULD HAVE A SHORTER DATE THAN THE ONYX 18 AND DMSO, AND THE ACCOUNT WAS WONDERING IF THE DEVICE WAS PACKAGED THIS WRONG. THE EVENT WAS NOT ASSOCIATED WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19795513 ↗

Other Micro Therapeutics, Inc. products

• PipelineTM Flex Embolization Device with Shield TechnologyTM79 models · 1,020 reports
• AxiumTM139 models · 832 reports · 1 recall
• PIPELINE114 models · 622 reports · 1 recall
• Concerto Detachable Coil System34 models · 595 reports
• Axium Prime Detachable Coil System70 models · 497 reports
• ConcertoTM70 models · 436 reports
• EchelonTM5 models · 225 reports · 2 recalls
• Axium Detachable Coil System69 models · 288 reports