AxiumTM APB-1.5-4-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00847536020962), received between Aug 12, 2019 and Mar 10, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME ES 3D COIL DID NOT DETACH. DETACHMENT WAS ATTEMPTED TWICE USING THE INSTANT DETACHER BUT WAS UNSUCCESSFUL; ONE EMERGENCY DETACHMENT WAS ALSO ATTEMPTED BUT COULD NOT BE PERFORMED (WAS UNSUCCESSFUL). SINCE THE DEVICE COULD BE STORED IN THE CATHETER, THE ENTIRE CATHETER WAS REMOVED. IT WAS REPORTED THERE WERE NO DEFECTS WITH THE INSTANT DETACHER. THE COIL WAS REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT INTERNAL CAROTID ARTERY (LT. ICA BOUTHILLIER CLASSIFICATION C5 CLINOID SEGMENT) ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. 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 24558836 ↗
• MalfunctionFeb 3, 2026Unintended Movement; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED LEFT INTERNAL CAROTID ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 2.7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE SECOND AXIUM COIL WAS BEING INSERTED, POOR FIT WAS OBSERVED, AND RESISTANCE WAS FELT DURING REPEATED INSERTION AND WITHDRAWAL. WHEN AN ATTEMPT WAS MADE TO WITHDRAW IT AS IS, RESISTANCE DISAPPEARED PARTWAY, BUT THE FIRST COIL OF THE SAME SIZE (SAME LOT) THAT HAD ALREADY BEEN INSERTED CAME OUT OF THE ANEURYSM, AND RETRIEVAL WAS PERFORMED WITH A SNARE. THERE WAS COIL EXTENSION, KINKING, AND DAMAGE. THE COIL WAS REPOSITIONED 1 TIME. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. THE DEVICE WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THERE WAS COIL DAMAGE/EARLY DISLODGEMENT. THE COIL WAS REMOVED FROM THE BODY. IT WAS COLLECTED WITH THE DELIVERY WIRE. NO ADDITIONAL SURGICAL OR MEDICAL TREATMENT WAS PERFORMED. THERE WAS NO DEFORMATION OR DAMAGE TO THE DELIVERY PUSHER. THERE WAS NO RESISTANCE DURING DELIVERY. COIL DISLODGEMENT WAS NOT ATTEMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247202 ↗
• MalfunctionFeb 3, 2026Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED LEFT INTERNAL CAROTID ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 2.7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE SECOND AXIUM COIL WAS BEING INSERTED, POOR FIT WAS OBSERVED, AND RESISTANCE WAS FELT DURING REPEATED INSERTION AND WITHDRAWAL. WHEN AN ATTEMPT WAS MADE TO WITHDRAW IT AS IS, RESISTANCE DISAPPEARED PARTWAY, BUT THE FIRST COIL OF THE SAME SIZE (SAME LOT) THAT HAD ALREADY BEEN INSERTED CAME OUT OF THE ANEURYSM, AND RETRIEVAL WAS PERFORMED WITH A SNARE. THERE WAS COIL EXTENSION, KINKING, AND DAMAGE. THE COIL WAS REPOSITIONED 1 TIME. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. THE DEVICE WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THERE WAS COIL DAMAGE/EARLY DISLODGEMENT. THE COIL WAS REMOVED FROM THE BODY. IT WAS COLLECTED WITH THE DELIVERY WIRE. NO ADDITIONAL SURGICAL OR MEDICAL TREATMENT WAS PERFORMED. THERE WAS NO DEFORMATION OR DAMAGE TO THE DELIVERY PUSHER. THERE WAS NO RESISTANCE DURING DELIVERY. COIL DISLODGEMENT WAS NOT ATTEMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247181 ↗
• MalfunctionJul 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE AXIUM COIL WAS PLACED IN THE INTENDED POSITION WITHIN THE PATIENT'S BODY, THE COIL HAD PREMATURE DISLODGEMENT. THERE WAS NO ADDITIONAL SURGICAL OR MEDICAL TREATMENT PERFORMED. THERE WAS NO DEFORMATION OR DAMAGE IN THE DELIVERY PUSHER. THERE WAS NO RESISTANCE DURING DELIVERY, THE COIL WAS NOT REPOSITIONED, AND NO DISLODGEMENT WAS ATTEMPTED. THE DELIVERY PUSHER DID NOT ROTATE INSIDE THE PATIENT'S BODY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED 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 22374129 ↗
• MalfunctionOct 24, 2024Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WOULD NOT DETACH. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 6 MM AND NECK DIAMETER 3 MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND THE VESSEL TORTUOSITY WAS MODERATE. WHEN THE SURGEON USED THE COIL TO EMBOLIZE THE MIDDLE CEREBRAL ARTERY ANEURYSM, HE USED THE QC5-10-3D COIL. THE EMBOLIZATION WAS SATISFACTORY, AND WHEN HE WAS READY TO DETACH THE COIL, HE USED THE ALTERNATIVE DETACHMENT METHOD AND BROKE THE SPARE DETACHMENT POINT BY HAND AND FOUND THAT THE COIL WAS NOT DETACHED. HE PULLED OUT THE DETACHMENT WIRE FOR OBSERVATION AND FOUND THAT THE PROXIMAL END OF THE DETACHMENT WIRE WAS SHORT AND BROKE IN ADVANCE. THE PHYSICIAN USED STERILE NEEDLE-NOSED PLIERS TO TWIST OFF THE PROXIMAL PUSHER ROD, FOUND THE TAIL END OF THE BROKEN DETACHMENT WIRE IN THE PUSHER ROD AND PULLED IT OUT, AND THEN THE DETACHMENT WAS SUCCESSFUL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. A MANUAL ATTEMPT AT DETACHMENT VIA HYPO

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 20521739 ↗
• MalfunctionAug 20, 2024Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY AND ANOTHER AXIUM COIL THAT DETACHED PREMATURE OR BROKE/SEPARATED DURING THE SAME PROCEDURE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RIGHT ANTERIOR COMMUNICATING ARTERY (ACOM) RUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COILS AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS DELIVERED IN PLACE FOR THE EMBOLIZATION PROCEDURE. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE AXUM COIL (MODEL: QC-2-6-3D, LOT: 227053086) HAD SIGNIFICANT RESISTANCE DURING DELIVERY THROUGH THE MIDDLE SEGMENT OF THE MICROCATHETER. IT WAS REMOVED AND REPLACED WITH ANOTHER SIZE BARE AXIUM 3D (QC-2-4-3D) WHICH WAS DELIVERED AND DEPLOYED SUCCESSFULLY. DURING THE SAME PROCEDURE ANOTHER AXIUM COIL (MODEL: APB-1.5-4-HX, LOT: 227008025) WAS BEING USED. THERE WAS FRICTION OR SOME DIFFICULTY DURING DELIVERY OF THE COIL. DURING THE FILLING PROCESS, THE SURGEON SAID THE COIL WAS STRETCHED. THE PHYSICIAN HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009042 ↗
• MalfunctionJan 30, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR A SUBDURAL BLEED. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. THE PATIENT WAS UNDERGOING MIDDLE MENINGEAL ARTERY (MMA) EMBOLIZATION TO THE RIGHT SIDED ANTERIOR MIDDLE MENINGEAL ARTERY BRANCH. THE COIL WAS ADVANCED WITHOUT ISSUE AND SUCCESSFULLY DEPLOYED WITHIN THE MMA BRANCH. THE INSTANT DETACHER (ID) WAS THEN PLACED ONTO PROXIMAL PUSHER WIRE AND DETACHED. UPON REMOVING THE PUSHER WIRE, IT WAS NOTICED THE AXIUM PRIME COIL WAS STILL ATTACHED. THE COIL WAS REPOSITIONED AND DETACHMENT WAS RETRIED, BUT STILL THE COIL WOULD NOT DETACH. THE PHYSICIAN THEN MANUALLY BROKE PUSHER WIRE SEGMENT TO MANUALLY DETACH COIL AND IT STILL WOULD NOT DETACH. THE COIL WAS REMOVED AND A REPLACEMENT COIL WAS DETACHED WITHOUT ISSUE. IT WAS REPORTED THAT 3 DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE FIRST ID, AND 2 DETACHMENT ATTEMPTS HAD BEEN MADE WITH A SECOND ID. TWO MANUAL DETACHMENT ATTEMPTS HAD ALSO BEEN ATTEMPTED. IT WAS STATED THAT THERE WERE NO ISSUES WITH THE ID. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610197 ↗
• MalfunctionMay 11, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ***MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENT REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION INDICATES A REPORTABLE EVENT.***

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805502 ↗
• MalfunctionJan 7, 2020Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DETACHED FROM THE PUSH ROD PREMATURELY AND THE PUSHWIRE WAS KINKED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, LEFT PICA ANEURYSM WITH A MAX DIAMETER OF 2.5MM AND A 1.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER FILLING FOUR SPRING COILS, THE AXIUM COIL WAS TO BE USED AS THE CLOSING COIL. THE COIL WAS NORMALLY DELIVERED INTO THE MICROCATHETER, AND SLOWLY ADJUSTED INTO THE ANEURYSM. LARGE RESISTANCE WAS FELT DISTALLY WITH A SLIGHT KINK IN THE PROXIMAL END WHEN PUSHING. DUE TO THE UNSATISFACTORY SHAPE WITH THE COIL ENTERING THE ANEURYSM, THE SURGEON RETRIEVED THE COIL FOR ADJUSTMENT. AFTER THE COIL WAS RETRIEVED TO THE MICROCATHETER, THE SURGEON SUDDENLY FOUND THE PUSH ROD WAS RETRIEVED, BUT THE SPRING COIL REMAINED IN THE MICROCATHETER. THE SPRING COIL AND PUSH ROD WERE REMOVED FROM THE PATIENT'S BODY AS A WHOLE UNIT, AND THE CONNECTION JOINT BETWEEN THE SPRING COIL AND PUSH ROD WAS FOUND TO BE DISENGAGED. A GUIDEWIRE WAS USED TO PUSH THE SPRING COIL OUT OF THE TUBE. IT WAS NOTED THE COIL AND PUSH ROD WERE AUTOMATICALL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9559624 ↗
• MalfunctionAug 12, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT, AFTER COIL PLACEMENT, THE PHYSICIAN TRIED TO DETACH THE COIL USING THE INSTANT DETACHER. HOWEVER, WHEN THE PUSHWIRE WAS EXTRACTED THROUGH THE MICROCATHETER IT SHOWED THAT THE COIL DID NOT DETACH. IN ORDER TO PREVENT COMPLICATIONS NO SECONDARY DETACHMENT WAS ATTEMPTED, AND THE COIL WAS REPLACED. THE MICROCATHETER AND GUIDEWIRE WERE USED FOR FURTHER COIL PLACEMENT AND THEN DISCARDED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 2.5MM AND A NECK DIAMETER OF 1MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. 1 DETACHMENT ATTEMPT WAS MADE WITH THE INSTANT DETACHER, NO OTHER DETACHMENT WAS ATTEMPTED. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8884611 ↗