Apollo 105-5096-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00763000446758), received between May 8, 2023 and Sep 25, 2026 — classified as 4 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (39 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Compatibility Problem; Material Deformation; Physical Resistance/Sticking

  Medtronic received a report that resistance was encountered in the proximal end of an Apollo microcatheter during Onyx liquid embolic injection and the microcatheter occluded. The patient was undergoing surgery for treatment of an arteriovenous malformation (AVM). It was noted the patient's vessel tortuosity was moderate. Right femoral artery access vessel diameter was 7 mm. An intermediate catheter was used to advance the Apollo microcatheter to the target lesion, and embolization was initiated. After flushing the catheter with DMSO and preparing to inject Onyx, it was found that Onyx could not come out from the microcatheter. The operator then attempted to inject Onyx while withdrawing the microcatheter, but Onyx still could not come out and the resistance was very high. The microcatheter was then removed from the patient's body and DMSO was injected, but the resistance remained high and nothing could come out. A new microcatheter (Echelon 10 model 105-5091-150, lot 0232208029) was subsequently used instead, and the procedure was completed successfully. No patient symptoms or complications were associated with this event. The reported device and any accessory devices were prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899732 ↗
• InjurySep 25, 2026Burst Container or Vessel; Leak/Splash

  Medtronic received a report that Onyx was being used for embolization of an arteriovenous fistula (AV fistula). An Apollo 3 cm tip microcatheter was used to deliver the Onyx. The Apollo was advanced through the middle meningeal artery (MMA) feeder, and the Onyx was flowing as intended with minimal reflux. At one point, the Onyx was still flowing, but it was no longer visible on the roadmap image, which had been magnified on the fistula. The physician did not feel any pressure during injection and stopped when the flow could no longer be seen. After zooming out, the physician observed that the Onyx was also flowing proximally due to a hole in the Apollo microcatheter. This caused Onyx to flow into the petrosal branch and resulted in facial paralysis in the patient. The reported issue was a catheter leak, located distally, which was observed during use despite the catheter having been inspected and tested prior t o use. It was noted the patient's vessel tortuosity was normal. Access vessel was the MMA. The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (IFU). Ancillary devices include a Guide catheter, Apo

  Patient problems: Facial Paralysis; Paralysis

  MAUDE report 50899068 ↗
• MalfunctionSep 25, 2026Burst Container or Vessel; Compatibility Problem; Material Deformation; Physical Resistance/Sticking

  Medtronic received a report that an Apollo catheter occluded and ruptured (intact) during Onyx 34 injection. The patient was undergoing Onyx liquid embolization surgery. It was noted the patient's vessel tortuosity was moderate. MMA  access vessel diameter was 1.5 mm. No patient symptoms or complications were associated with this event. Slight Onyx embolus visible in proximal MMA, was not blocking flow appeared to be no effects on patient. Physician felt resistance pushing Onyx and catheter slightly buckled, all of a sudden noticed dark spot on fluoro about 30-40cm proximal to catheter tip in proximal MMA. Pulled catheter out and catheter was clearly ruptured mid-catheter at a proximal portion of orange segment. The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (IFU). The catheter was inspected or tested prior to use. The catheter occlusion occurred during Onyx injection. There was friction or difficulty during delivery. The injection rate was unknown at the time of reporting; typical injection rate lower than 0.3mL/min.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898067 ↗
• MalfunctionSep 18, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829641 ↗
• MalfunctionSep 3, 2026Detachment of Device or Device Component

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

  MAUDE report 50590811 ↗
• MalfunctionAug 12, 2026Difficult to Remove; Separation Failure; Physical Resistance/Sticking

  Patient problems: Vasoconstriction

  MAUDE report 50221258 ↗
• MalfunctionJun 17, 2026Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN APOLLO CATHETER ENCOUNTERED RESISTANCE AT THE DISTAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A ARTERIOVENOUS MALFORMATION FLUID EMBOLIZATION. IT WAS NOTED THE PATIENT'S ACCESS VESSEL WAS THE FEMORAL ARTERY AND THAT VESSEL TORTUOSITY WAS MODERATE. DURING LIQUID EMBOLIZATION TREATMENT FOR AN ARTERIOVENOUS MALFORMATION, AFTER ADVANCING THE MICROCATHETER TO THE DESIGNATED SITE DURING THE PROCEDURE, SIGNIFICANT RESISTANCE WAS ENCOUNTERED UPON INJECTING THE EMBOLIC AGENT, WITH MINIMAL FLOW OBSERVED FROM THE TIP. INSPECTION OF THE MICROCATHETER AND ITS ASSOCIATED SYSTEM REVEALED A KINK APPROXIMATELY 5 CM FROM THE DISTAL END OF THE MICROCATHETER; CONSEQUENTLY, THE MICROCATHETER WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE KINK WAS OBSERVED AT THE DISTAL SECTION OF THE CATHETER. THE CATHETER WAS FLUSHED AND ALL DEVICES WERE PREPPED AS INDICATED IN THE IFU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED. FACILITY AND PHYSICIAN¿S CONTACT INFORMATION WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536391 ↗
• MalfunctionApr 16, 2026Compatibility Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION USING THE APOLLO CATHETER, THE CATHETER BECAME BLOCKED AFTER FOLLOWING THE STANDARD PREPARATION PROCESS, WHICH INCLUDED FLUSHING WITH DMSO SOLVENT AND INJECTING THE EMBOLIC AGENT. THE BLOCKAGE PREVENTED FURTHER INJECTION OF THE EMBOLIC AGENT. THE SAME ISSUE OCCURRED WHEN A SECOND APOLLO CATHETER. THE CATHETER WAS THEN REPLACED WITH A MARATHON FLOATING MICROCATHETER, ALLOWING THE PROCEDURE TO PROCEED NORMALLY. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9.5MM AND NORMAL VESSEL TORTUOSITY. THE CATHETER AND ACCESSORY DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE BLOCKAGE WAS NOT DETERMINED. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THERE WAS NO RESISTANCE DURING FLUSHING OR DMSO FILLING, AND NO KINK OR DAMAGE WAS OBSERVED ON THE CATHETER. ONYX REFLUX WAS PRESENT, BUT THE VOLUME OF REFLUX IS UNKNOWN. THE PHYSICIAN PAUSED DURING INJECTION, WITH WAITING TIMES BETWEEN INJECTIONS RANGING FROM 30 SECONDS TO 2 MINUTES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896652 ↗
• MalfunctionApr 7, 2026Burst Container or Vessel; Leak/Splash; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING ARTERIOVENOUS FISTULA SURGERY, AFTER THE INTERMEDIATE CATHETER WAS POSITIONED, THE MICROCATHETER WAS REMOVED AND FLUSHED. LEAKAGE WAS OBSERVED DUE TO RUPTURE OF THE MICROCATHETER. THE MICROCATHETER WAS REPLACED, AND THE PROCEDURE CONTINUED. THERE WAS CATHETER LEAK IN THE DISTAL SECTION. THE CATHETER WAS INSPECTED OR TESTED PRIOR TO USE. THE LEAK WAS OBSERVED DURING PREPARATION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800178 ↗
• MalfunctionApr 3, 2026Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IT WAS UNKNOWN IF THERE WERE ANY CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT IDENTIFIED. THE GUIDEWIRE WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779742 ↗
• MalfunctionMar 18, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF PREMATURE DETACHMENT OF AN APOLLO CATHETER TIP. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE RADIAL ARTERY WITH A 3 MM VESSEL DIAMETER. IT WAS REPORTED THAT DURING REMOVAL OF THE MICROCATHETER, THE OPERATOR NOTED THAT THE DISTAL TIP OF THE MICROCATHETER DETACHED SPONTANEOUSLY. IT WAS NOTED THAT THERE WAS TIP PREMATURE DETACHMENT. NO FRICTION OR DIFFICULTY WAS OBSERVED DURING INJECTION. THERE WAS NO FORCE APPLIED DURING REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK. THERE WAS NO VASOSPASM. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. IT WAS NOT SPECIFIED IF THIS OCCURRED DURING ONYX INJECTION. 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. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632203 ↗
• MalfunctionMar 2, 2026Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT AN APOLLO MICROCATHETER RUPTURED DURING A SURGICAL PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A TAMPONADE MALFORMATION ANEURYSM, BY DELIVERY OF LIQUID EMBOLIZATION SYSTEM. IT WAS REPORTED THAT DURING SURGERY, THE DOCTOR USED A MICROCATHETER TO DELIVER A LIQUID EMBOLIZATION SYSTEM TO FILL AN ABNORMAL ANEURYSM. DURING THE PROCEDURE, THE MICROCATHETER RUPTURED. THE DOCTOR IMMEDIATELY MONITORED THE PATIENT'S VITAL SIGNS, WHICH SHOWED NO ABNORMAL FLUCTUATIONS. DSA EXAMINATION OF THE CEREBRAL VESSELS REVEALED LOCALIZED LEAKAGE OF EMBOLIC MATERIAL, BUT NO DAMAGE TO OTHER VESSELS. POSTOPERATIVE EXAMINATION SHOWED STABLE VITAL SIGNS AND NO BODILY DAMAGE. AFTER REMOVAL OF THE ENDOTRACHEAL TUBE AND 30 MINUTES OF OBSERVATION WITHOUT ANY SPECIAL ISSUES, THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC ICU. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483546 ↗
• MalfunctionFeb 3, 2026Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT DURING ONYX LIQUID EMBOLIC INJECTION, THE DISTAL END OF THE APOLLO MICROCATHETER RUPTURED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTRACRANIAL CEREBROVASCULAR MALFORMATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. RIGHT FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 6.0 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. IT WAS UNKNOWN IF THERE WAS ANY OTHER DAMAGE TO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248095 ↗
• MalfunctionJan 26, 2026Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DAMAGED APOLLO CATHETER WAS NOT FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184719 ↗
• MalfunctionJan 26, 2026Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  ON (B)(6) 2026 MPXR (B)(4) (FOR, HCP, REP): MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR ARTERIOVENOUS MALFORMATION TREATMENT. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT A LIQUID EMBOLIZATION PROCEDURE FOR A CAVERNOUS SINUS ARTERIOVENOUS FISTULA WAS PERFORMED USING AN APOLLO CATHETER. PREOPERATIVE PREPARATION AND OPERATION WERE CARRIED OUT ACCORDING TO THE INSTRUCTIONS, AND ONYX WAS DELIVERED. DURING THE ESTABLISHMENT OF THE SURGICAL PATHWAY, A PREMATURE DETACHMENT EVENT OCCURRED AT THE TIP END OF THE APOLLO MICROCATHETER. THE TIP END WAS DETACHED SPONTANEOUSLY BEFORE REACHING THE FISTULA SITE. THE SURGEON ATTEMPTED TO USE A BALLOON CATHETER TO RETRIEVE THE DETACHED PORTION BUT WAS UNSUCCESSFUL. THE SL-10 MICROCATHETER WAS THEN USED AS A REPLACEMENT, POSITIONED AGAINST THE DETACHED APOLLO, TO DELIVER THE ONYX GLUE. THE DELIVERY WAS SUCCESSFUL, AND THE SURGERY WAS COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE

  Patient problems: Foreign Body In Patient

  MAUDE report 24182907 ↗
• MalfunctionDec 11, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER WAS DAMAGED DURING HYDRATION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE ASSISTANT TOOK OUT THE APOLLO CATHETER FROM THE PACKAGING AS USUAL AND PERFORMED ROUTINE HYDRATION. DURING HYDRATION, IT WAS FOUND THAT THERE WAS NO DETACHMENT ZONE AT THE TIP END, WHICH LED TO A COMPLAINT BEING RAISED. THE DEVICE WAS THEN REPLACED WITH ANOTHER APOLLO, WHICH DID NOT EXHIBIT ANY ABNORMALITIES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT EXPERIENCED NO ADVERSE REACTIONS POSTOPERATIVELY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED PER THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782834 ↗
• InjuryDec 3, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR A LEFT FRONTAL LOBE MALFORMATION, CEREBRAL HEMORRHAGE, 2CM IN SIZE. THERE WAS MODERATE TO SEVERE VESSEL TORTUOSITY. THE PATIENT HAD A BRAIN HERNIATION AND RIGHT-SIDED HEMIPLEGIA. THE TIP PORTION (25CM) REMAINED INSIDE THE SKULL, WHILE THE REST WAS REMOVED. THE ANEURYSM WAS NOT TREATED. NO FURTHER INTERVENTIONS OR TREATMENT WERE PERFORMED. THE CUSTOMER INDICATED THAT THE DSA EQUIPMENT IMAGING WAS NORMAL.

  Patient problems: Foreign Body In Patient; Intracranial Pressure Increased; Paralysis

  MAUDE report 23705238 ↗
• MalfunctionNov 17, 2025Break; Leak/Splash; Break; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR LEFT VERTEBRAL ARTERY VENOUS MALFORMATION EMBOLIZATION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE RIGHT FEMORAL ARTERY, WITH 6.3MM DIAMETER.  IT WAS REPORTED THAT AFTER THE APOLLO MICROCATHETER WAS POSITIONED, GLUE INJECTION WAS INITIATED. IT WAS OBSERVED THAT THE GLUE WAS LEAKING FROM THE PROXIMAL END OF THE MICROCATHETER TIP. UPON WITHDRAWING THE MICROCATHETER, A RUPTURE WAS FOUND IN THE DISTAL SHAFT OF THE MICROCATHETER.  THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. ASIDE FROM RUPTURE, THERE NO OTHER DAMAGE TO THE CATHETER. THE INJECTION RATE WAS 0.25ML/MIN. NO 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576644 ↗
• MalfunctionNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS TREATED FOR EMBOLIZATION OF THE EXTERNAL CAROTID ARTERY. NO ACTIONS OR INTERVENTIONS WERE TAKEN TO RESOLVE THE TIP PREMATURE DETACHMENT, AS THE DETACHED TIP REMAINS IN THE PATIENT AND WILL NOT BE RETURNED FOR ANALYSIS. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED, AND IT OCCURRED DURING DELIVERY WITHIN THE VESSEL. THE DETACHABLE SEGMENT AT THE TIP OF THE MICROCATHETER DETACHED WITHIN THE VESSEL, SPECIFICALLY IN THE EXTRACRANIAL SEGMENT OF THE CAROTID ARTERY. THERE WAS NO RESISTANCE WHEN ADVANCING OR RETRIEVING THE APOLLO, AND THE TIP IS NOT EMBEDDED IN THE ONYX CAST. THERE ARE NO FUTURE PLANS TO RETRIEVE THE CATHETER TIP. THE SUBJECT IS CURRENTLY RECOVERING WITHOUT ABNORMALITIES, AND NO VESSEL CALCIFICATION WAS NOTED. THE MODEL AND LOT NUMBER OF THE GUIDE CATHETER ARE UNKNOWN, WHILE THE GUIDE WIRE USED WAS AN ASAHI-10, WHICH WAS HYDRATED AS INDICATED IN THE IFU. NO KINK OR DAMAGE WAS NOTICED ON ANY OF THE DEVICES, AND A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE GUIDE CATHETER DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23543277 ↗
• MalfunctionNov 5, 2025Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS AN ARTERIOVENOUS FISTULA. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED. THE DEVICE PACKAGING WAS NOT DAMAGED ON DELIVERY. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479878 ↗
• MalfunctionOct 27, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS DIAGNOSED WITH AN INTRACRANIAL ARTERIOVENOUS MALFORMATION (AVM). THE SURGEON USED A .010 MICRO GUIDEWIRE TO SUPER-SELECT THE DISTAL MALFORMED VESSELS, SUCCESSFULLY ADVANCING THE GUIDEWIRE DISTALLY. HOWEVER, THE APOLLO MICROCATHETER COULD NOT TRACK AND BE PUSHED TO GO UPPER DESPITE MULTIPLE ATTEMPTS. THE SURGEON INDICATED THAT THERE MIGHT BE AN ISSUE WITH THE INNER DIAMETER OF THE MICROCATHETER. AFTER REPLACING TO A MARATHON MICROCATHETER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WAS RESISTANCE IN THE DISTAL SECTION OF THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 10 MM. THE PATIENT IS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE MICROGUIDEWIRE COULD NOT COME OUT, AND THE SURGEON CONSIDERED WHETHER THE MICROCATHETER'S INNER DIAMETER WAS TOO SMALL TO COME OUT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23397326 ↗
• MalfunctionOct 15, 2025Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FISTULA ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. THE PATIENT IS CURRENTLY RECOVERING WELL. NO SYMPTOMS RELATED TO THE LEAK. THE CAUSE OF THE LEAK IS UNKNOWN. APOLLO RUPTURE WAS CONFIRMED DURING HYDRATION; ONYX WAS NOT INJECTED. THE LIQUID EMBOLIC AGENT WAS NOT IMPLANTED, SO NO MEDICAL INTERVENTION WAS REQUIRED. THE ANATOMICAL LOCATION OF THE APOLLO TIP WAS IN THE DETACHABLE ZONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23300822 ↗
• MalfunctionAug 18, 2025Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED, AND THERE WERE NO ISSUES THAT RESULTED IN THE DEVICE DAMAGE THAT WAS FOUND. NO PREP WAS PERFORMED PRIOR TO THE DAMAGE BEING SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22833389 ↗
• MalfunctionAug 15, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. ONYX WAS USED AS THE LIQUID EMBOLIC DURING THE PROCEDURE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE TIP DETACHMENT OCCURRED DURING NAVIGATION THROUGH THE GUIDE CATHETER. NO KINK OR DAMAGE WAS NOTICED ON ANY OF THE DEVICES DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 22813578 ↗
• MalfunctionAug 12, 2025Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking; Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE INJECTION PROCESS, THE CATHETER'S DETACHMENT SECTION ACCIDENTALLY DETACHED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 10MM.

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

  MAUDE report 22785063 ↗