AxiumTM APB-4-10-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536008090), received between Dec 11, 2018 and Jul 7, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR ANEURYSM ON THE RIGHT SIDE WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS STRONG. IT WAS REPORTED THAT ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL COULD NOT BE DETACHED AFTER 3 ATTEMPTS USING THE INSTANT DETACHER. NO ADDITIONAL INSTANT DETACHERS WERE USED. ONE MANUAL DETACHMENT ATTEMPT HAD BEEN MADE VIA THE HYPOTUBE THE COIL WAS REPLACED WITH ANOTHER MANUFACTURER¿S DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22417487 ↗
• MalfunctionMay 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MICROCATHETER USED WAS A HEADWAY 17.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235730 ↗
• MalfunctionMar 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THERE WERE NO DETACHMENT ATTEMPTS, IT WAS AUTOMATICALLY DETACHED. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS REMOVED FROM THE PATIENT. THE CATHETER USED WAS AN ECHELON 10. THERE WAS ONE COIL IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816569 ↗
• MalfunctionJan 4, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE AXIUM COIL WAS PUSHED INTO THE MICROCATHETER FOR THE FIRST TIME, THE RESISTANCE WAS INCREASED. IT WAS OBSERVED THAT THE AXIUM COIL HAD BEEN AUTOMATICALLY STRETCHED BY THE END OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE AXIUM COIL WITH ANOTHER SPRING COIL. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT TRY AND REPOSITION THE COIL DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM WITH A MAX DIAMETER OF 5.1MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18443890 ↗
• MalfunctionJun 2, 2023Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED T-S: TRANSVERS SINUS. TVE: TRANSVENOUS EMBOLIZATION. THE COIL UNEXPECTEDLY DETACHED AFTER NOT DETACHMENT. THE COIL DETACHED IN THE CATHETER. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL IS IMPLANTED (IMPLANTED SLIGHTLY OUT OF PLACE). NO ADDITIONAL ACTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049068 ↗
• MalfunctionJul 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO INSERT THE COIL INTO THE ANEURYSM AS THE FIRST FRAMING COIL, THE FRAMING COULD NOT BE COILED UP WELL. WHEN IT WAS INSERTED AND RETRACTED SEVERAL TIMES, IT WAS CONCLUDED THAT IT PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED WITH THE MICROCATHETER AND THE ENTIRE COIL DELIVERY WIRE SYSTEM. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED NORMALLY. THERE WAS NO DEFORMATION OR DAMAGE TO THE DELIVERY PUSHER, AND THERE HAD BEEN NO RESISTANCE DURING DELIVERY. THE COIL HAD BEEN REPOSITIONED 5 OR MORE TIMES. NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER INSIDE THE PATIENT. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15117423 ↗
• MalfunctionJan 19, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DID NOT DETACH. THE PATIENT WAS BEING TREATED FOR A SACCULAR UNRUPTURED ANEURYSM IN THE IC-PC. THE MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS STRONG. THE DEVICES WAS PREPARED AS INDICATED IN THE PACKAGE INSERT.  THE COIL COULD NOT BE DETACHED, TRIED TO CUT IT USING THE DETACHER FOR 3 TIMES, BUT IT COULD NOT BE CUT, SO IT WAS COLLECTED. THE OTHER COILS COULD BE DETACHED. THE PHYSICIAN TRIED TO DETACH THE COIL USING INSTANT DETACHER 3 TIMES. THE PHYSICIAN DID NOT TRY USING ANOTHER INSTANT DETACHER. THERE WAS NOT A MANUAL ATTEMPT TO DETACH IT THROUGH THE MEDIUM OF HYPOTUBE. THERE WAS NO INSTANT DETACHER MALFUNCTION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13290083 ↗
• MalfunctionDec 22, 2021Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL HAS NOT PROGRESSED IN THE SHEATH INTO THE MICROCATHETER, WHICH REQUIRED REPLACEMENT OF THE DEVICE. THE NEXT AXIUM COIL WAS INSERTED INTO THE MICROCATHETER AND RESISTANCE WAS OBSERVED. WHEN REMOVING THE DEVICE, IT WAS OBSERVED THAT THE SPIRAL WAS "UNMAKING" INSIDE THE MICROCATHETER. THE DEVICE WAS REMOVED AND EXCHANGED FOR ANOTHER DEVICE. THE DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM IN A PREVIOUS COMMUNICATOR WITH AN UNKNOWN MAX D IAMETER AND AN UNKNOWN NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A ECHELON 10 45 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR STATED THAT ABOUT THE SPIRAL HAVING DISSOLVED: WHEN THE MIRCOCOIL PASSED INSIDE THE MICROCATHETER, RESISTANCE WAS FELT. BY THE TIME THEY REMOVED THE MICROSPRING FROM THE DEVICE, THE SPRING WAS UNDONE, LOSING ITS ORIGINAL SHAPE, AND ALMOST DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13060450 ↗
• MalfunctionNov 3, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NOTHING IN PARTICULAR THAT LED TO THE COIL NON-DETACHMENT. THERE SEEMED TO BE NO PROBLEM IN PARTICULAR BY VISUAL INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746695 ↗
• MalfunctionJan 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE PHYSICIAN PUSHED THE AXIUM COIL THROUGH THE ECHELON MICROCATHETER, THE COIL WAS DETACHING TOO EARLY. THE COIL WAS IN THE VENOUS SYSTEM, AND THE PHYSICIAN USED A WIRE TO CATCH THE COIL, BUT WAS UNABLE TO PULL THE COIL BACK INTO THE CATHETER. AS A RESULT, THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT IN ORDER TO REMOVE THE COIL. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED, NO RESISTANCE WAS FELT DURING DELIVERY, AND THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WERE NO ATTEMPTS TO DETACH THE COIL MADE, AND IT WAS UNKNOWN IF THE COIL HAD BEEN REPOSITIONED OR ROTATED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11170967 ↗
• MalfunctionJan 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DOCTOR RAISED THE ECHELON 10 MICROCATHETER AND THE MICROGUIDE, AND POSITIONED THE CATHETER ON THE ANEURYSM. THE MICROGUIDE WAS TAKEN OUT, AND THE AXIUM COIL WAS INSERTED INTO THE CATHETER HUB. THE THREE-WAY VALVE WAS OPENED TO HYDRATE THE IT, BUT WHEN THE COIL WAS ADVANCED, THERE WAS RESISTANCE IN THE PROXIMAL SEGMENT OF THE CATHETER. AFTER SEVERAL ATTEMPTS WERE MADE, THE DOCTOR REMOVED THE COIL WITH ITS SHEATH. A REPLACEMENT COIL WAS THEN USED WHICH WAS DELIVERED WITHOUT RESISTANCE. THE REPORTED COIL WAS THEN USED AGAIN, BUT THE SAME RESISTANCE WAS EXPERIENCED AGAIN. THERE WAS NO DAMAGE TO THE CATHETER, BUT THE IMPLANT COIL WAS DAMAGED. TWO OTHER COILS WERE THEN USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. IT WAS REPORTED THE MICROCATHETER FUNCTIONED CORRECTLY, AND THERE WAS NO ALLEGATION AGAINST THE ECHELON MICROCATHETER. 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 PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 4 MM AND A 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11158104 ↗
• MalfunctionJul 7, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT FIVE AXIUM COILS HAD PROBLEMS WITH RESISTANCE IN SHEATH, RESISTANCE IN CATHETER, AND RESISTANCE IN HUB. THE PHYSICIAN FINALLY CONNECTED A TUOHY AND SEATED NEW COILS CORRECTLY TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING PERIPHERAL TREATMENT. THE BLOOD FLOW WAS HIGH AND THE VASCULATURE WAS MODERATE IN TORTUOSITY. IT WAS NOT THAT THE PHYSICIAN WAS USING AXIUM COILS AND ECHELON MICROCATHETER IN AN OFF-LABEL MANNER FOR PERIPHERAL THERAPY BECAUSE THEY DID NOT HAVE ANY PERIPHERAL DETACHABLE COILS AVAILABLE. THE PHYSICIAN WAS NOT TRAINED ON THE NEURO COILS. THE COILS WERE NOT BEING FLUSHED AND A CONTINUOUS FLUSH WAS NOT ADMINISTERED THROUGH THE TUOHY. THE REP BELIEVED THAT THE PHYSICIAN WAS NOT PROPERLY SEATING THE INTRODUCED WITH THE HUB. THE COILS WERE ABLE TO BE PUSHED SMOOTHLY OUT FROM THE INTRODUCED SHEATH. THERE WAS NO DAMAGE OBSERVED ON THE CATHETER. ADDITIONAL INFORMATION RECEIVED REPORTING THAT COIL WAS STUCK IN THE PROXIMAL END OF THE CATHETER. THE COILS WERE NOT HYDRATED. ANALYSIS RESULTS FOUND THE PUSHWIRE WAS BROKEN AT THE PROXIMAL SEGMENT, AND THE COIL WAS ALREADY DETACHED A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10239367 ↗
• MalfunctionDec 26, 2019Separation Failure; Detachment of Device or Device Component; Activation Failure; Separation Failure; Detachment of Device or Device Component; Activation Failure

  MEDTRONIC RECEIVED REPORT THAT SL-10 WAS TO DELIVER THE AXIUM COIL INTO THE INTENDED LOCATION. DETACHMENT WAS ATTEMPTED. ALTHOUGH DETACHMENT WAS ATTEMPTED SEVERAL TIMES WITH THE DETACHER, THE DETACHMENT WAS NOT SUCCESSFUL, SO THE BREAK INDICATOR WAS BROKEN, THE FILAMENT INSIDE WAS PULLED OUT TO TRY TO DETACH IT, BUT THE COIL DID NOT DETACH. AFTER THAT, IT WAS REQUESTED TO DELIVER SLIGHTLY BEYOND THE SECOND MARKER AND ATTEMPT TO DETACH THE COIL. SEVERAL ATTEMPTS TO ADVANCE AND WITHDRAW THE DEVICE, BUT THE ISSUE PERSISTED. SO, THE DEVICE WAS REMOVED CAREFULLY FROM THE MICROCATHETER AND WAS SUCCESSFULLY RETRIEVED. THE COIL DETACHED DURING THE RETRIEVE. THREE DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. A SECOND DETACHER WAS NOT USED. ONE MANUAL DETACHMENT WAS MADE. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT INTERNAL CAROTID ARTERY (C3). THE ANEURYSM WAS UNRUPTURED AND SACCULAR. THE MAX DIAMETER WAS 6MM AND THE NECK WAS MM. THE BLOOD FLOW WAS NORMAL, AND THE VESSEL ANATOMY WAS MODERATE IN TORTUOSITY. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9520685 ↗
• InjuryJun 4, 2019Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE COIL EMBOLIZATION OF AN ANEURYSM, THE PATIENT STARTED TO EXHIBIT STROKE LIKE SYMPTOMS. THE PATIENT RECEIVED A HEAD CT, AND IT WAS DETERMINED THAT ONE OR MORE OF THE COILS HAD PROTRUDED FROM THE ANEURYSM AND INTO THE PARENT VESSEL. IT WAS STATED THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-WITH INJURY. A CLOT FORMED ON THE COIL, EMBOLISM TREATED, AND PATIENT WAS RECOVERING. THE PATIENT HAD UNDERGONE COIL IMPLANTATION TO TREAT A RUPTURED, AMORPHOUS ANEURYSM LOCATED AT THE LEFT INTERNAL CAROTID ARTERY, POS TERIOR COMMUNICATING ARTERY TERRITORY WITH A MAX DIAMETER OF 5.2MM AND A NECK DIAMETER OF 3MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MINIMAL. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: Embolus; Ischemia

  MAUDE report 8669241 ↗
• MalfunctionDec 11, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE DEVICE WOULD NOT DETACH, AFTER SEVERAL ATTEMPTS WITH AN INSTANT DETACHER, AND BY USING A MANUAL DETACHMENT METHOD. AS A RESULT THE PHYSICIAN SLOWLY PULLED OUT THE INSIDE OF THE MICROCATHETER AND COLLECTED THE COIL. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER DEVICE. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR A 4MM CEREBRAL ANEURYSM. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A STRYKER SL-10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8150753 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab