AxiumTM APB-3-4-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536021075), received between Feb 21, 2020 and Jan 22, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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.

• MalfunctionJan 22, 2026Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER THE DEVICE WAS REPLACED WITH A MEDTRONIC PRODUCT. THE CAUSE OF THE NON-DETACHMENT WAS UNKNOWN. NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT. IT IS UNKNOWN WHETHER ANY PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153339 ↗
• MalfunctionNov 27, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO THE NON-DETACHMENT. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE, AND THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801146 ↗
• MalfunctionSep 10, 2024Break; Unintended Movement; Break; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL BECAME STUCK WHEN RETRACTING AND BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COIL WAS INSERTED INTO THE THIRD COIL USED HAD THE PROBLEM. WHEN THE COIL WAS BEING INSERTED AND WHEN RETRACTED IT SUDDENLY BECAME STUCK INSIDE THE CATHETER, MAKING IT IMPOSSIBLE TO PUSH OR RETRACT. BECAUSE 2 LOOPS HAD ALREADY BEEN IN THE ANEURYSM, THE CATHETER WAS PULLED AND THE COIL WAS PLACED IN THE BODY IN A WAY THAT DEVIATED FROM THE MOTHER BLOOD VESSEL. THE COIL WAS IMPLANTED IN THE INTENDED POSITION, AND NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO DAMAGE NOTED TO THE PUSHER. IT WAS STATED THAT THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. ONE DETACHMENT ATTEMPT HAD BEEN MADE WITH THE INSTANT DETACHER, AND NO MANUAL DETACHMENT ATTEMPTS WERE MADE. THE COIL HAD BEEN REPOSITIONED 2 TIMES. THE HAD BEEN NO RESISTANCE DURING PREPARATION OR DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN ADMINI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186661 ↗
• MalfunctionDec 21, 2023Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE WHEN PLACING THE COIL; THE COIL WAS BROKEN WHEN THE DELIVERY WIRE WAS PULLED BACK. AFTER COLLECTION, THE TREATMENT WAS COMPLETED WITHOUT USING ANOTHER PRODUCT. THERE WAS COIL EXTENSION OF THE EMBOLIZATION COIL. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE COIL WAS NOT REPOSITIONED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 18377348 ↗
• MalfunctionJul 12, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WERE NO PROBLEMS WHEN THE PRIME HELIX3X6 WAS PLACED. AFTERWARDS, WHEN THE PRODUCT WAS POSITIONED IN A SIMILAR LOCATION, IT COULD NOT BE DETACHED, THE DELIVERY WIRE WAS BROKEN SO IT WOULD NOT WORK. WHEN THE COIL WAS BEING REMOVED TO COLLECT IT, A STRONG RESISTANCE WAS ENCOUNTERED AND IT COULD NOT BE REMOVED. IN THE END, THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER SEVERAL TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. 1 MANUAL DETACHMENT ATTEMPT WAS MADE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE A-COM WITH A MAX DIAMETER OF 10X5X5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE: AXCELGUIDE 6F, DD-6, HEADWAY DUO, AND A CHIKAI14.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14996128 ↗
• MalfunctionMar 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PUSHWIRE WAS STUCK IN THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 6MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS DELIVERED AND PLACED IN THE ANEURYSM FOR DETACHMENT. IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE COIL DETACHED, HOWEVER, THE PUSHWIRE WAS STUCK IN THE INSTANT DETACHER (ID). THEREFORE, THE PUSHWIRE AND ID WERE RETRIEVED TOGETHER, AND A NEW ID WAS USED TO COMPLETE THE PROCEDURE. 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. ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884282 ↗
• MalfunctionFeb 21, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM AND A SMALL NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT A FEW COILS HAD ALREADY BEEN IMPLANTED WITHOUT ISSUE, AND THEN THE AXIUM COIL WAS INSERTED INTO THE ANEURYSM, BUT WOULD NOT DETACH WITH THE INSTANT DETACHER (ID). THE ID WAS USED THREE TIMES, THE MANUAL DETACHMENT METHOD WAS PERFORMED, BUT THE COIL STILL FAILED TO DETACH. THE AXIUM COIL WAS CAREFULLY REMOVED FROM THE MICROCATHETER, AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. 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. ANCILLARY DEVICES INCLUDE A 6F TERUMO, 6F ENVOY, ECHELON 10, TRAXCESS GUIDEWIRE, AND SCEPTERHX 4/11.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9741555 ↗