Axium Prime Detachable Coil System APB-3-8-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000313975), received between Jul 14, 2022 and Sep 24, 2026 — classified as 1 death, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884578 ↗
• MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE ORDER OF SPRING COILS USED: APB-3-8-HX-ES, LOT: 229175220; APB-2-4-HX-ES, LOT: 229241627; APB-1.5-4-HX-ES, LOT: 229439735. COILS WITH LOT#'S: 229439735 AND 229241627 SUCCESSFULLY IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293175 ↗
• MalfunctionSep 16, 2025Separation Failure; Device Dislodged or Dislocated; Separation Failure; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS NON-DETACHMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES. THE PHYSICIAN TRIED TO DETACH WITH ANOTHER INSTANT DETACHER TWICE. THERE WERE TWO MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENTS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE PATIENT IS ALIVE WITH NO INJURY. DURING A NEUROINTERVENTIONAL PROCEDURE FOR EMBOLIZATION OF AN INTRACEREBRAL ANEURYSM WITH A COIL, THE COIL DID NOT DETACH CORRECTLY AT THE TIME OF DETACHMENT. THE COIL GUIDE WAS REMOVED, LEAVING A PROTRUSION WITH A RISK OF EXITING THE ANEURYSM LOCATION. PRIOR TO THIS, THE COIL DETACHMENT HAD BEEN PERFORMED APPROPRIATELY USING THE DETACHMENT SYSTEM ACCORDING TO THE COIL¿S TYPE AND BRAND. THE COIL WAS CAPTURED IN THE MICROCATHETER TO PREVENT COIL MIGRATION OR ESCAPE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM AT THE BIFURCATION OF THE LEFT INTERNA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066701 ↗
• MalfunctionJul 23, 2025Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE AB STENT FAILED TO DETACH. THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, UNRUPTURED LEFT INTERNAL CAROTID ANTERIOR COMMUNICATING SEGMENT ANEURYSM WITH UNKNOWN DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE SOLITAIRE AB STENT WAS BEING USED FOR ANEURYSM COILING WITH A REMODELING TECHNIQUE. DURING THE DETACHMENT PHASE, THE DEVICE FAILED TO RELEASE. TROUBLESHOOTING STEPS INCLUDED BATTERY REPLACEMENT, CABLE CHANGES, AND REPLACEMENT OF THE DETACHMENT BOX, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE SETUP FOLLOWED STANDARD PROTOCOL: THE RED CABLE WAS CONNECTED TO THE PUSHER WIRE, THE BLACK CABLE TO THE NEEDLE, AND THE PUSHWIRE WAS PLACED ON A CLEAN, DRY SURFACE. AS DETACHMENT COULD NOT BE ACHIEVED AND REMOVING THE STENT WOULD HAVE LED TO COIL DISPLACEMENT, THE PHYSICIAN DECIDED TO CUT THE PUSHER WIRE, LEAVING THE STENT IN PLACE. NO ADVERSE EFFECTS WERE REPORTED, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT, DURING A FOLLOW-UP MEDICAL VISIT AFTER THE PROCEDURE, REPORTED EXPERIENCING NECK PAIN WHEN TURNING THEIR HEAD, DESCRIBING IT AS A PULLING SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580458 ↗
• MalfunctionJun 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE GUIDE CATHETER WAS PASSED TO THE WORKING TABLE, THROUGH WHICH A 0.035 HYDROPHILIC GUIDEWIRE WAS ADVANCED, REACHING THE COMMON CAROTID ARTERY. THE GUIDEWIRE WAS REMOVED AND THE MICROCATHETER WAS ADVANCED. IT WAS MOUNTED ON A 0.014 GUIDEWIRE THROUGH THE INTERNAL CAROTID ARTERY. AFTER PERFORMING ANGIOGRAPHIC ACQUISITIONS, MEASUREMENTS OF THE LEFT INTERNAL CAROTID ARTERY WERE TAKEN. THE PHYSICIAN REQUESTED AN APB 3 X 8 CM HELIX COIL. THE DEVICE WAS PURGED WITH HEPARINIZED SOLUTION. THE COIL WAS ADVANCED THROUGH THE MICROCATHETER, WHICH DID NOT ADVANCE. THE PHYSICIAN REQUESTED ANOTHER ONE. THE COIL WAS STUCK IN THE CATHETER. THERE WAS NO DAMAGE TO THE CATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO INJURY AS A RESULT OF THIS EVENT. THIS EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22246033 ↗
• MalfunctionApr 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR CEREBRAL ARTERY, THERE WAS AN ISSUE WITH THE AXIUM PRIME BARE HX 3MM X 8CM EXTRA COIL, WHICH EXPERIENCED RESISTANCE AND BECAME STUCK IN THE SHEATH. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 4 MILLIMETERS AND A NECK DIAMETER OF 2.5 MILLIMETERS, WITH NORMAL BLOOD FLOW AND MODERATE VESSEL TORTUOSITY. IMAGES WERE AVAILABLE FOR REVIEW. A BACKUP UNIT WAS USED TO ADDRESS THE ISSUE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED THAT IT CANNOT BE CONCLUDED WHAT CAUSED THE SECOND COIL TO BE STUCK IN THE SLEEVE. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION AS THE SECOND COIL DID NOT COME OUT OF THE SLEEVE AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903538 ↗
• DeathJul 14, 2022Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT WHEN FIRST USING THE APB-5-15-3D-SS AND APB-3-10-HX-ES THERE WAS SUCCESS WITH BOTH PRODUCTS. THE PROXIMAL LOBE WAS FRAMED WITH APB-4-8-3D-SS AND HAD NO ISSUES, THE BASKET WAS FILLED WITH APB-3-8-HX-ES AND THIS IS WHEN A COMPLICATION WAS ENCOUNTERED. THE APB-3-8-HX-ES WAS FILLING THE SAC WELL UNTIL ABOUT 2CM WAS LEFT TO GO IN WHEN SUDDENLY IT STARTED TO PROTRUDE INTO THE PARENT ARTERY SO IT WAS PULLED BACK AND TRIED TO REPOSITION THE MICROCATHETER IN THE ANEURYSM. THEN THEY PROCEEDED TO ADVANCE THE COIL AGAIN AND PROTRUSION OCCURRED AGAIN. AN ATTEMPT WAS MADE TO PUSH IN THE REMAINDER OF THE COIL WHEN ALL OF SUDDEN THE DOCTOR SAID THAT THE REMAINDER OF THE COIL INSIDE THE MICROCATHETER WAS NOT MOVING. THEY REMOVED THE MICROCATHETER OUT OF THE ANEURYSM SAC AND IT WAS DISCOVERED THAT THE COIL HAD DETACHED THUS REMAINDER OF THE COIL REMAINED IN A2. THEY TRIED TO SNARE THE COIL OUT FOR SEVERAL HOURS WITH NO LUCK, THEY THEN TRIED GIVING THE AVIGO A SHAPE AND ENTANGLING IT WITH THE OUTSIDE PIECE OF THE COIL TO TRY AND SNARE IT OUT THAT WAY BUT IT TOO WAS UNSUCCESSFUL. WHILE ATTEMPTING TO HOOK THE COIL, THE AVIGO WIRE BROKE IN A2 LEADING TO THE ICA SO NOW TH

  Patient problems: Device Embedded In Tissue or Plaque; Stroke/CVA

  MAUDE report 15024607 ↗