ONYX 34 105-7100-080 (UDI 00847536006188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847536006188), received between Jan 24, 2019 and Jan 14, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (2 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 10 most recent of 10 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 WAS RECEIVED REPORTING THAT THE LIQUID EMBOLIC AGENT WAS IMPLANTED IN THE MIDDLE MENINGEAL ARTERY (MMA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069048 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT UNDERWENT ONYX EMBOLIZATION FOR A DURAL AV FISTULA AND BECAME A PARAPLEGIC.

  Patient problems: Paraplegia

  MAUDE report 17484612 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT WAS RECOVERED/RESOLVED ON (B)(6) 2023.

  Patient problems: Bacterial Infection; Cognitive Changes; Cyst(s); Dysphasia; Encephalopathy; Fever; Swelling/ Edema; Unspecified Nervous System Problem

  MAUDE report 16702969 ↗
• MalfunctionFeb 10, 2023Entrapment of Device; Entrapment of Device

  NEW INFORMATION WAS RECEIVED. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THERE WAS NO KINK OR DAMAGE ON THE CATHETER THAT WAS NOTICED.  THE INJECTION WAITING TIME OR PAUSE TIME BETWEEN THE INJECTIONS WAS AS PER PROTOCOL. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MOST CURRENT PATIENT CONDITION "IS OKAY WAITING FOR FOLLOWING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354884 ↗
• MalfunctionJan 21, 2022Entrapment of Device; Entrapment of Device

  MEDTRONIC RECEIVED A REPORT THAT THE SCEPTORC BALLOON WAS STUCK IN THE ONYX AT TARGET VESSEL. HUB WAS CLIPPED AND CATHETER WAS LEFT IN PATIENT. ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THEY WERE SUCCESSFULLY TREATED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT FOR ARTERIOVENOUS MALFORMATION (AVM). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13318858 ↗
• MalfunctionOct 28, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE REMAINING ONYX HAD BEEN DISCARDED AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10751861 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT A CAUSE FOR THE BLOOD PRESSURE SPIKING AND HEMORRHAGE WAS NOT DETERMINED.

  Patient problems: High Blood Pressure/ Hypertension; Intracranial Hemorrhage

  MAUDE report 10504187 ↗
• MalfunctionMay 11, 2020Component or Accessory Incompatibility; Component or Accessory Incompatibility

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE AVM WAS LOCATED ON THE PATIENT'S RIGHTSIDE INVOLVING THE EXTERNAL CAROTID AND MIDDLE CEREBRAL ARTERIES. THE ONYX INJECTION WAS CONTINUOUS; THE PHYSICIAN DID NOT PAUSE. THE DEAD SPACE OF THE CATHETER WAS FILLED WITH DIMETHYL SULFOXIDE (DMSO). THERE WAS NO FURTHER SURGICAL OR MEDICAL INTERVENTION REQUIRED DUE TO THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10042572 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF BACTERIAL INFECTION AFTER ONYX EMBOLIZATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT ENDOGRAPH LEAK REPAIR USING ONYX 18 AND ONYX 34. APPROXIMATELY 70 DAYS POST-EMBOLIZATION, THE PATIENT PRESENTED AT THE HOSPITAL WITH A SEVERE AORTIC INFECTION CAUSED BY BACTERIA. THE NAME OF THE BACTERIA WAS NOT PROVIDED, BUT IT WAS REPORTEDLY A SKIN-TRANSMISSIBLE MICROORGANISM. THE PATIENT UNDERWENT SURGERY TO REMOVE THE ONYX; THE CUSTOMER IS REPORTEDLY IN POSSESSION OF THE ONYX MATERIAL. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Bacterial Infection

  MAUDE report 8307595 ↗
• MalfunctionJan 24, 2019Component or Accessory Incompatibility; Component or Accessory Incompatibility

  MEDTRONIC RECEIVED INFORMATION THAT THE ONYX WAS NOT VISIBLE UNDER FLUOROSCOPY. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) WAS DONE AND ONYX SHOWED UP WELL UNDER THE CT. PRIOR TO THE EVENT, A PROWLER 14 WAS PLACED PROXIMAL TO THE ARTERIOVENOUS MALFORMATION (AVM) AND ONYX WAS INJECTED BUT IT WAS SUSPECTED THE ONYX WAS NOT VISIBLE AND THAT THE AVM MAY HAVE BEEN OCCLUDED BEFORE ANY ONYX WAS VISIBLE. THE ONYX WAS REPORTED TO HAVE BEEN SHAKEN FOR MORE THAN 20 MINUTES ON SPEED SETTING OF 6/7. THE ONYX VIALS DID NOT SIT FOR MORE THAN 20 MINUTES AND IT WAS INJECTED IMMEDIATELY AFTER MIXING. POST PROCEDURAL ANGIOGRAPHY SHOWED COMPLETED VESSEL OCCLUSION AND THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S VASCULATURE WAS MINIMAL IN TORTUOSITY. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE INJECTION WAS CONTINUOUS. THE DURATION OF THE ONYX INJECTION WAS 5 MINUTES. ANCILLARY DEVICES: PROWLER 14 MICROCATHETER, ENVOY 5F GUIDE CATHETER, SIEMENS BIPLANE FLUOROSCOPIC EQUIPMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8273916 ↗