Apollo 105-5095-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000446741), received between Aug 24, 2023 and Sep 10, 2026 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713943 ↗
• MalfunctionAug 20, 2026Detachment of Device or Device Component

  Additional information was received reporting that no causes or contributing factors for the event were identified. On the DSA screen, the surgeon observed that a segment of the catheter tip appeared to be detached. There was no resistance when the Apollo was being advanced. The detached tip does not remain in the patient and it will not be returned. There has been no adverse events to report. There was no note of vessel calcification. It was asked but unknown what guidewire was used. The guidewire was hydrated as indicated in the IFU. There was no kink or damage noticed on any of the devices. A continuous salineflush was administered and maintained as indicated in the IFU.

  Patient problems: Foreign Body In Patient

  MAUDE report 50347232 ↗
• MalfunctionApr 14, 2026Compatibility Problem

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER WOULD NOT FLUSH; NO SALINE WOULD COME OUT OF DISTAL TIP. AS PER THE SURGICAL TECH AND PHYSICIAN A CATHETER OCCLUSION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION RECEIVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT APOLLO CATHETER. THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING OBSERVED ON THE PACKAGING DEVICE. IT WAS UNKNOWN IF THERE WAS KINKS OR DAMAGE THAT WERE NOTED ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879902 ↗
• MalfunctionApr 3, 2026Burst Container or Vessel; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT AN APOLLO CATHETER WAS OBSERVED TO HAVE A LEAK AT THE DISTAL LOCATION DURING USE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. WHILE EMBOLIZING THE AVM WITH ONYX, THE PHYSICIAN NOTICED ONYX EXITING THE CATHETER ABOUT 10CM FROM THE TIP. THE CATHETER WAS REMOVED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. RIGHT INTERNAL CAROTID ARTERY (ICA) ACCESS VESSEL DIAMETER WAS 2 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777990 ↗
• MalfunctionFeb 19, 2026Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN WAS INJECTING ONYX AND NOTICED IT WAS COMING OUT PROXIMAL TO THE DETACHMENT ZONE OF THE APOLLO. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS A PATIENT INVOLVED IN THIS EVENT. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388876 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED, AND THE OPERATOR STATED THAT IT OCCURRED DURING NORMAL OPERATION. THE TIP DETACHMENT OCCURRED DURING ADVANCEMENT OF THE MICROCATHETER; WHEN THE OPERATOR ADJUSTED THE TENSION, IT WAS OBSERVED THAT THE TIP MARKER AND THE CATHETER DID NOT ADVANCE OR RETRACT SYNCHRONOUSLY. NO OBVIOUS RESISTANCE WAS REPORTED DURING ADVANCEMENT OR WITHDRAWAL OF THE APOLLO, AND NO RESISTANCE WAS REPORTED DURING RETRIEVAL. THE DETACHED TIP WILL NOT BE RETURNED FOR ANALYSIS BECAUSE IT WAS LOST. THE APOLLO TIP WAS NOT EMBEDDED IN THE ONYX CAST AND WAS NOT INSIDE THE PATIENT, SO NO RETRIEVAL WAS REQUIRED AND NO ANATOMICAL LOCATION APPLIES. THE PATIENT HAD A GOOD POSTOPERATIVE OUTCOME, AND NO ADVERSE EVENTS WERE REPORTED AT THIS TIME. THERE WAS NO VESSEL CALCIFICATION NOTED BY THE OPERATOR. THE GUIDE CATHETER WAS NOT A MEDTRONIC PRODUCT, AND THE GUIDEWIRE USED WAS A STRYKER 0.010 INCH GUIDEWIRE THAT WAS HYDRATED NORMALLY PER THE IFU. NO KINK OR DAMAGE WAS NOTICED ON ANY OF THE DEVICES, AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE GUIDE CATHETER DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24322485 ↗
• InjuryJan 14, 2026Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER TIP DETACHED. THE PATIENT WAS UNDERGOING ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION SURGERY. THE ACCESS VESSEL WAS THE RIGHT INTERNAL CAROTID ARTERY WITH A DIAMETER OF 6 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE TIP OF APOLLO CATHETER BROKE OFF WHILE TRYING TO CANNULATE THE DISTAL A2-A3 JUNCTION. THE SEPARATION/BREAK OCCURRED DURING USE AT THE DISTAL SEGMENT. A 1.5 CM BROKEN FRAGMENT REMAINS IN THE PATIENT AT THE DISTAL A2/A3 LOCATION. THERE WAS NO FRICTION OR DIFFICULTY DURING THE INJECTION. THERE WAS FORCE APPLIED DURING DELIVERY/REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED/STRUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A BMX 71 SHEATH, AN APRO 55 GUIDE CATHETER, AND A SYNCHRO 10 GUIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24076085 ↗
• MalfunctionDec 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION OF THE CATHETER. 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 ARTERIOVENOUS MALFORMATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 2MM. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830095 ↗
• MalfunctionDec 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT WHEN THE APOLLO CATHETER WAS IN PLACE, THE DETACHABLE TIP DETACHED PREMATURELY. IT WAS NOTED THAT THE APOLLO CATHETER AND ALL ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS NOTED THAT PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING AN ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION PROCEDURE VIA FEMROAL ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729505 ↗
• MalfunctionNov 10, 2025Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT DURING THE EMBOLIZATION PROCEDURE FOR AN EXTERNAL CAROTID ARTERY AVM, AFTER THE 8F GUIDING CATHETER REACHED THE OPENING OF THE EXTERNAL CAROTID ARTERY, THE CHIKAI10 GUIDEWIRE WAS USED TO GUIDE IT INTO THE APOLLO MICROCATHETER (MODEL: 105-5095-000, LOT: B798476). BOTH THE MICROCATHETER AND GUIDEWIRE WERE THOROUGHLY HYDRATED, AND THE PROCESS WAS SMOOTH. THE MICROCATHETER WAS ADVANCED VIA THE EXTERNAL CAROTID ARTERY APPROACH INTO THE MALFORMATION NIDUS. AFTER FLUSHING THE MICROCATHETER LUMEN WITH NORMAL SALINE, DMSO WAS INJECTED, FOLLOWED BY ONYX GLUE (MODEL: 105-7000-060, LOT: B809303). THE INJECTION WAS PERFORMED AT A STEADY RATE, AND NO RESISTANCE OR CATHETER BLOCKAGE WAS OBSERVED. THE ONYX GLUE DISPERSED WELL. HOWEVER, DURING CONTINUED INJECTION, ONYX GLUE WAS FOUND TO BE LEAKING FROM A POINT APPROXIMATELY 5 CM PROXIMAL TO THE DETACHMENT SITE. THE OPERATION WAS THEN STOPPED AND THE MICROCATHETER WAS REMOVED. CATHETER LEAK WAS IN THE MIDDLE SECTION. THE CATHETER WAS INSPECTED OR TESTED PRIOR TO USE. THE LEAK WAS OBSERVED DURING USE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTI

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

  MAUDE report 23511449 ↗
• MalfunctionNov 4, 2025Burst Container or Vessel; Leak/Splash; Material Rupture; Material Deformation; Burst Container or Vessel; Leak/Splash; Material Rupture; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ASIDE FROM THE ABNORMAL VISUALIZATION OF ONYX, THERE WERE NO OTHER ISSUES WITH THE PRODUCT. NO ISSUES WITH THE GUIDEWIRE (MODEL 103-0608, LOT NO. D050584) AND NAVIEN CATHETER. THE ANATOMICAL LOCATION OF THE APOLLO TIP WAS THE DISTAL END OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23466333 ↗
• MalfunctionJun 17, 2025Leak/Splash; Difficult to Remove; Leak/Splash; Difficult to Remove

  MEDTRONIC RECEIVED A REPORT THAT MEDTRONIC RECEIVED A REPORT THAT DURING USE IT WAS NOTICED A LEAK IN MIDDLE SECTION OF THE APOLLO CATHETER. THE PATIENT WAS UNDERGOING TREATMENT OF RECURRENT ARTERIOVENOUS MALFORMATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH 7MM DIAMETER. IT WAS REPORTED THAT DURING THE RECURRENT MIDDLE CEREBRAL ARTERY AVM EMBOLIZATION, AFTER THE 8F GUIDE CATHETER REACHED THE EXTERNAL CAROTID ARTERY OPENING, THE 6F INTERMEDIATE CATHETER REACHED THE C5 SEGMENT OF THE INTERNAL CAROTID ARTERY AND WAS READY TO BE INSERTED INTO THE APOLLO MICROCATHETER THROUGH THE NON-MEDTRONIC GUIDE WIRE. THE MICROCATHETER AND GUIDE WIRE WERE FULLY HYDRATED, AND THE PROCESS WENT SMOOTHLY. THE MICROCATHETER ENTERED THE MALFORMATION THROUGH THE MIDDLE CEREBRAL ARTERY APPROACH, AND DMSO WAS INJECTED AFTER THE INJECTION OF NORMAL SALINE. THEN, ONYX GLUE WAS INJECTED. THE INJECTION PROCESS WAS SMOOTH, NO RESISTANCE OR TUBE BLOCKAGE WAS FOUND, AND THE ONYX GLUE WAS DIFFUSED. AFTER THE EMBOLIZATION PURPOSE WAS ACHIEVED, THE HEAD END WAS RELEASED, AND THE NEGATIVE PRESSURE WAS MAINTAINED TO WITHDRAW THE MICROCATHETER. AFTER THE W

  Patient problems: Coma; Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Loss of consciousness; Obstruction/Occlusion; Paraplegia; Stroke/CVA

  MAUDE report 22238179 ↗
• InjuryMar 19, 2025Break; Difficult to Remove; Break; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED REPORTED RACA NOT FILLING, POTENTIAL PTFE LINER STILL PRESENT. LACA COLLATERALIZING AND PATIENT IS MOVING L UPPER EXTREMITY 3/5, NO LOWER LIMB MOVEMENT. THERE WAS NO RESISTANCE UPON INJECTION OF THE LIQUID EMBOLIC AGENT INTO THE APOLLO. DURING INJECTION MULTIPLE PAUSES WITH TOTAL INJECTION TIME OF 9 MINUTES. THE INJECTION RATE WAS FOLOWED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). LIQUID EMBOLIC AGENT GOT EMBEDDED IN AN UNINTENDED LOCATION IN THE RA2. ADDITIONAL INTERVENTION WAS P THE OST EMBOLIZATION SURGICAL RESECTION OF AVM. THE ANATOMICAL LOCATION OF THE APOLLO TIP IS THE DISTAL A3.

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

  MAUDE report 21649265 ↗
• MalfunctionDec 10, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN EMBOLIZATION OF AN ARTERIOVENOUS MALFORMATION USING AN APOLLO CATHETER, A CATHETER LEAK WAS OBSERVED. THE LEAK WAS LOCATED IN THE MIDDLE OF THE CATHETER AND OCCURRED DURING USE. THE PROCEDURE INVOLVED ACCESSING THE FEMORAL ARTERY WITH MINIMAL VESSEL TORTUOSITY. A MICROCATHETER WAS PLACED DISTAL INTO THE ANTERIOR CEREBRAL ARTERY, AND A CONTRAST INJECTION WAS PERFORMED, REVEALING CONTRAST PROXIMAL TO THE TIP OF THE CATHETER. CONSEQUENTLY, THE CATHETER WAS PULLED OUT FROM THE BENCHMARK AND OUT OF THE PATIENT. THE DEFECTIVE CATHETER WAS DISCARDED AND REPLACED WITH A NEW ONE. ANCILLARY DEVICES INCLUDED CHIKAI .010" MICROWIRE AND ANOTHER MANUFACTURER'S GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892465 ↗
• MalfunctionJul 10, 2024Burst Container or Vessel; Material Deformation; Burst Container or Vessel; Material Deformation

  ADDITIONAL INFORMATION RECEIVED THAT THE INVOLVED PRODUCTS WERE NOT USED ON THE PATIENT, THE COMPLAINT WAS JUST COSMETIC ISSUE, THERE WAS NO RESISTANCE AND RUPTURE OF THE APOLLO OR THE ECHELON OR THE PED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19711081 ↗
• MalfunctionJan 3, 2024Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT AN APOLLO CATHETER LEAKED IN THE PROXIMAL SECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN INTRACRANIAL ARTERIOVENOUS MALFORMATION. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5.5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN USING THE MICROCATHETER FOR RADIOGRAPHY, IT WAS FOUND THAT THE CONTRAST AGENT COULD NOT BE INJECTED. AFTER REPEATED ATTEMPTS TO NO AVAIL, THIS MICROCATHETER WAS WITHDRAWN. WATER LEAKAGE WAS FOUND IN THE CATHETER BODY IN VITRO. THE SURGEON THOUGHT IT WAS A PRODUCT QUALITY PROBLEM AND REQUESTED TO RETURN IT FOR IDENTIFICATION. IT WAS REPORTED THERE WAS A CATHETER LEAK OBSERVED IN THE PROXIMAL SECTION DURING USE. 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 PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18438658 ↗
• MalfunctionDec 11, 2023Burst Container or Vessel; Packaging Problem; Burst Container or Vessel; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE DAMAGE WAS FOUND UPON OPENING THE PACKAGE, PRIOR TO ANY PREPARATION AND NO PREPARATION WAS COMPLETED. THERE WAS NO INVOLVEMENT OF ONYX WITH THE APOLLO COMPLAINT AS THE ISSUE WAS OBSERVED OUT-OF-PACKAGE AND THE APOLLO CATHETER WAS THEN NOT PREPARED OR USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301561 ↗
• MalfunctionAug 24, 2023Break; Difficult to Advance; Break; Difficult to Advance

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2023, THE PHYSICIAN WAS PREPARING TO PERFORM INTRACRANIAL INTERVENTIONAL EMBOLIZATION FOR THE PATIENT WITH ARTERIOVENOUS MALFORMATIONS IN THE PARIETAL ARTERY. DURING THE OPERATION, AFTER THE ACCESS WAS ESTABLISHED, UNDER THE GUIDANCE OF THE X-PEDION GUIDE WIRE, THE APOLLO FLOATING MICROCATHETER WAS SLOWLY PUSHED TO GO UPPER. AFTER THE TIP OF THE MICROCATHETER REACHED THE PROXIMAL END OF THE DISEASED VESSEL, IT COULD NOT BE PLACED IN PLACE AFTER REPEATED ADJUSTMENTS. AFTER REDUCING THE TENSION, WHEN TRYING AGAIN, IT WAS FOUND THAT THE DISTAL END WAS NOT AFFECTED BY THE TWIST CONTROL. THEN THE MICROCATHETER AND MICRO GUIDE WIRE SYSTEM WERE WITHDRAWN FROM THE BODY FOR OBSERVATION, AND IT WAS FOUND THAT THE DISTAL END OF THE APOLLO TUBE WAS BROKEN/SEPARATED AND THEN A NEW APOLLO WAS REPLACED. THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS FORCE APPLIED DURING THE DELIVERY. THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER AND THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE CATHETER WAS FLUSHED AND PRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17617828 ↗