Onyx 18 105-7100-060 (UDI 00836462005044)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00836462005044), received between Dec 19, 2019 and Jan 14, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, 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 ↗
• 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 ↗
• MalfunctionJan 17, 2024Migration or Expulsion of Device; Free or Unrestricted Flow; Migration or Expulsion of Device; Free or Unrestricted Flow

  ADDITIONAL INFORMATION WAS RECEIVED THAT ONYX WAS IMPLANTED AT THE INTENDED LOCATION. THE ONYX BURST FROM THE CATHETER A FEW CENTIMETERS FROM THE TIP. IT WAS CLARIFIED THAT THE FLOW TO THE FISTULA WAS SLOWED DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528454 ↗
• MalfunctionSep 25, 2023Entrapment of Device; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEAD SPACE OF 0.23ML. WAS FILLED WITH DMSO. DURING FLUSHING THERE WAS FRICTION AFTER INJECTING 0.25ML. ONYX-18. THERE WAS NO KINK OR DAMAGE ON THE CATHETER. THERE WAS NO ONYX¿REFLUX. IT WAS NOTED THAT THE INJECTION WAS CONTINUOUS. INITIALLY ONYX WAS DISPLACING DMSO, SO PHYSICIAN DIDN¿T PAUSE BETWEEN THE INJECTION TILL 0.25ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807130 ↗
• MalfunctionSep 25, 2023Entrapment of Device; Entrapment of Device

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEAD SPACE OF 0.25ML OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THERE WAS NO FRICTION DURING FLUSHING BUT THERE WAS DURING INJECTION, AFTER INJECTING 0.25ML ONYX-18. THERE WAS NO KINK OR DAMAGE ON THE CATHETER. THERE WAS NO ONYX REFLUX. INJECTION WAS CONTINUOUS. INITIALLY ONYX WAS DISPLACING DMSO, SO THE PHYSICIAN DIDN'T PAUSE BETWEEN THE INJECTION UNTIL 0.25ML. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807113 ↗
• MalfunctionApr 25, 2023Migration or Expulsion of Device; Premature Activation; Migration or Expulsion of Device; Premature Activation

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING EMBOLIZATION FOR ARTERIOVENOUS MALFORMATION (AVM) WITH INFLOW AROUND THE SUPERIOR SAGITTAL SINUS (SSS). MARATHON APPROACH FROM ANTERIOR CEREBRAL ARTERY (ACA) DISTAL. AFTER PLACEMENT IN THE TARGET VESSEL, 0.23 CC OF DMSO WAS INJECTED AFTER FLUSHING WITH SALINE. AFTER THAT, IT WAS REPLACED WITH AN ONYX SYRINGE WITH A CATHETER ADAPTER AND THE INJECTION WAS INITIATED. AFTER 90 SECONDS, THE FLUOROSCOPY COULD NOT CONFIRM THE INJECTION, SO UPON CHECKING THE HAND, IT WAS DISCOVERED THAT THE CATHETER HAD STOPPED MOVING AFTER 0.1 CC HAD BEEN INJECTED. DECIDING THAT IT MIGHT BE HARDENED IN THE CATHETER, THE CATHETER WAS REMOVED. FLUOROSCOPY ALSO CONFIRMED THAT NO ONYX WAS IN THE CATHETER. AFTER THAT, IT WAS SWITCHED TO ANOTHER PRODUCT AND THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED. PREMATURE COAGULATION OCCURRED. THE EMPTY SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THE PHYSICIAN DID NOT PAUSE DURING ONYX INJECTION. THE INJECTION RATE WAS IN ACCORDANCE WITH THE IFU. THE DURATION OF THE ONYX INJECTION WAS 90 SECONDS. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS UNDERGOING SURGERY FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809668 ↗
• InjuryFeb 15, 2023Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT REGARDING AN APOLLO CATHETER TIP NON DETACHMENT, CATHETER ENTRAPMENT, AND DIFFICULT REMOVAL. THE APOLLO CATHETER REMAINS IN THE PATIENT. THE PATIENT WAS UNDERGOING FISTULA EMBOLIZATION. THE ACCESSED VESSEL WAS THE OPHTHALMIC ARTERY WITH A DIAMETER OF LESS THAN 3 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PATIENT'S MEDICAL HISTORY INCLUDED AN ARTERIOVENOUS FISTULA. IT WAS REPORTED THAT THE PHYSICIAN ADVANCED THE APOLLO 1.5 CM TO THE OPHTHALMIC ARTERY AND COMPLETED SUCCESSFUL EMBOLIZATION OF THE FISTULA USING ONYX 18. WHEN REMOVING THE APOLLO CATHETER THE ARTERY MOVED SIGNIFICANTLY. THE DETACHABLE TIP DID NOT DETACH. THE PHYSICIAN INDICATED THAT THERE IS NO SUPPORT STRUCTURE IN THAT PART OF THE ANATOMY TO HOLD THE VESSEL IN PLACE AS HE REMOVED THE CATHETER. HE WAS CONCERNED ABOUT POSSIBLE TEARING OF THE ARTERY IF HE USED TOO MUCH FORCE SO HE DECIDED TO LEAVE THE CATHETER IN PLACE. HE TRIMMED THE HUB OFF THE APOLLO AND REMOVED THE RIST CATHETER AND SHEATH AND CUT THE APOLLO CATHETER AT WRIST. THEN PUT THE PATIENT ON ASPIRIN. IT WAS REPORTED THERE WAS CATHETER ENTRAPMENT/DIFFICULT REMOVAL DURING ONYX INJECTION.  THE INJECTION RATE OF

  Patient problems: Foreign Body In Patient

  MAUDE report 16379731 ↗
• MalfunctionApr 14, 2022Display or Visual Feedback Problem; Improper Chemical Reaction; Display or Visual Feedback Problem; Improper Chemical Reaction

  MEDTRONIC RECEIVED INFORMATION THAT AN ONYX HAD POOR VISUALIZATION BECAUSE THE ONYX DID NOT MIX PROPERLY. THE PATIENT WAS BEING TREATED FOR A ARTERIOVENOUS MALFORMATION (AVM) GRADE 3 THAT WAS NOT IN A N ELOQUENT REGION. VESSEL TORTUOSITY WAS MODERATE. ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  ONYX 18 HAD BEEN SHAKING AT 8:30AM AT SPEED OF 8 FOR 30 MINUTES WAS THEN BROUGHT DOWN TO SPEED OF 5 AND DRAWN UP TO INJECT AT 10:45AM. PHYSICIAN INJECTED ONYX INTO MICROCATHETER TO TREAT AVM AND SAID ONYX WAS NOT VISIBLE UNDER FLUORO BECAUSE IT WAS NOT SHAKEN PROPERLY. THE ONYX WAS SHAKEN FOR  2 HOURS. IT DID NOT SIT FOR MORE THAN 5 MINUTES PRIOR TO INJECTION. THE PHYSICIAN DID NOT HEAT, SHAKE, AND RE-HEAT THE ONYX VIALS PRIOR TO ASPIRATION. THE PHYSICIAN INJECTED THE ONYX IMMEDIATELY AFTER MIXING. PHYSICIAN USED ONYX 34 PRIOR WITH NO PROBLEMS. CASE WITH COMPLETED. NO PATIENT SYMPTOMS WERE REPORTED.  ANCILLARY DEVICES: HEADWAY DUO 156 MICROCATHETER, SYNCHRO 10 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116431 ↗
• MalfunctionMar 22, 2021Display or Visual Feedback Problem; Premature Activation; Display or Visual Feedback Problem; Premature Activation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICES USED IN THE EVENT WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE CAUSE OR THE POOR VISIBILITY AND PREMATURE SOLIDIFICATION WERE UNKNOWN. ALL DEVICES WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546085 ↗
• InjuryApr 2, 2020Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT THAT THE TIP OF A DEFLECTOR CATHETER BROKE OFF DUE TO ONYX ENTRAPMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ARTERIOVENOUS FISTULA (AVF) WITH NORMAL VESSEL TORTUOSITY. IT WAS REPORTED THAT THE DEFLECTOR CATHETER WAS DIFFICULT TO REMOVE DURING ONYX INJECTION, AND THE TIP BROKE OFF WHICH REMAINED IN THE PATIENT. NO ADDITIONAL SURGICAL OR MEDICAL PROCEDURES WERE PERFORMED TO REMOVE THE CATHETER TIP. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9917989 ↗
• InjuryFeb 13, 2020Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED REPORT THAT RESISTANCE WAS FELT WHEN THE MARATHON CATHETER WAS ATTEMPTED TO BE RETRIEVED. THE MARATHON CATHETER EVENTUALLY BROKE AT THE DISTAL SECTION, AS IT WAS STUCK IN THE ONYX. THE CATHETER DISTAL SECTION WAS LEFT IN THE SUPERIOR CEREBELLAR ARTERY (SCA). THE PATIENT DID NOT HAVE NEUROLOGICAL DETERIORATION POST THE INTERVENTION. EMBOLIZE THE SCA WITH ONYX18 (ABOUT 10 MINUTES) AND THE MARATHON WAS PULLED TO RETRIEVE. THE INTERMEDIATE CATHETER FUBUKI 4.2 WAS RAISED AND SUPPORT WAS PROVIDED, BUT IT WAS UNABLE TO RETRIEVE IT. THE DEVICE WAS BROKEN DURING PULLING. THE INJECTION WAS INTERRUPTED FOR BASIC 30 SECONDS UNIT. MAX120 SECONDS. THERE WAS A BACKFLOW THAT WAS ABOUT 1CM. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE ARTERIOVENOUS MALFORMATION (AVM) WAS IN THE SUPERIOR CEREBELLAR ARTERY (SCA). THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9706918 ↗
• InjuryDec 19, 2019Entrapment of Device; Migration or Expulsion of Device; Entrapment of Device; Migration or Expulsion of Device

  MEDTRONIC RECEIVED INFORMATION THAT THE PATIENT DEVELOPED A CEREBRAL INFARCTION A FEW DAYS AFTER MEDTRONIC LIQUID EMBOLIC EMBOLIZATION TREATMENT. PRIOR TO THE EVENT, THE MEDTRONIC LIQUID EMBOLIC WAS INJECTED FROM THE DISTAL END OF THE LEFT PICA. IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE MICROCATHETER BECAUSE THE TIP WAS STUCK. ONCE THE CATHETER WAS REMOVED, THERE WAS SEPARATION AND MOVEMENT OF AN MEDTRONIC LIQUID EMBOLIC LUMP. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM). THE MEDTRONIC LIQUID EMBOLIC EMBOLIZATION WAS PERFORMED IN THE LEFT PICA, BUT THE POSTOPERATIVE MRI CONFIRMED CEREBRAL INFARCTION IN THE PC AREA. THIS EVENT OCCURRED DURING THE TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM), THE FEEDER WAS SEVERELY TORTUOUS. ONYX WAS INJECTED AT 0.25 / 90 SECONDS. IT WAS REPORTED THAT THERE WAS ONYX REFLUX TO THE CATHETER, THERE WAS SOME RESISTANCE, BUT IT WAS NOT HARD TO REMOVE THE CATHETER. REMOVAL OF NIDUS WAS PERFORMED. THERE WAS NO VASOSPASM. SOME LEFT VISUAL FIELD DISORDER REMAINED. THE CONDITION WAS NOT VERY GOOD SINCE BLEEDING OCCURRED ORIGINALLY. THE PATIENT WAS PLANNED TO BE TRANSFERRED TO A REHABILITATION FACILI

  Patient problems: Infarction, Cerebral

  MAUDE report 9498878 ↗