ApolloRecalls & reported problems across all models

We found 2 models of Apollo by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between May 8, 2023 and Sep 25, 2026 — classified as 6 injuries, 95 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (44 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 Apollo problems

Apollo models

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

• Apollo 105-5096-000

  Agent, injectable, embolic
  83 reports
• Apollo 105-5095-000

  Agent, injectable, embolic
  18 reports

Recent Apollo adverse event reports

The 15 most recent reports across all models, 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 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713943 ↗
• MalfunctionSep 3, 2026Detachment of Device or Device Component

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

  MAUDE report 50590811 ↗
• 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 ↗
• 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 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 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 ↗
• 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 ↗
• 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 ↗

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