AxiumTM APB-2.5-6-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536021211), received between Apr 1, 2019 and May 3, 2024 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL FAILED TO DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR A BRAIN ANEURYSM. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER. A SECOND INSTANT DETACHER WAS NOT USED. MANUAL DETACHMENT WAS ATTEMPTED AND IT WAS CONFIRMED VISUALLY THAT THE FILAMENT CAME OUT, BUT THE COIL COULD NOT BE DETACHED. IT WAS NOTED THAT THERE WERE NO PROBLEMS WITH THE INSTANT DETACHER, AND IT HAD BEEN USED TO DETACH 5 OTHER COILS NORMALLY DURING THE PROCEDURE. THE COIL THAT COULD NOT BE DETACHED WAS THE THIRD COIL USED. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A RIST GUIDE CATHETER, SL-10 MICROCATHETER, AND SYNCHRO SOFT GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240378 ↗
• MalfunctionApr 12, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THREE AXIUM COILS ENCOUNTERED RESISTANCE IN THE CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX D IAMETER OF 4 MM AND A 2 MM NECK DIAMETER. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 7 MM. IT WAS NOTED THEPATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ON (B)(6), 2024, THE DOCTOR FOUND THAT THE AXIUM SPRING COIL COULD NOT ENTER THE MICROCATHETER DURING THE O PERATION. AFTER WITHDRAWING, IT WAS FOUND THAT THE SPRING COIL WAS STRETCHED OUTSIDE THE BODY. EVEN IF IT WAS REPLACED WITH THE SAME MODEL SPRING COIL, IT STILL COULD NOT ENTER THE MICROCATHETER. THE SURGEON REPLACED IT WITH APB-2.5-4-3D-ES, ALTHOUGH THE RESISTANCE WAS HIGH, IT WAS FINALLY DEPLOYED SUCCESSFULLY. THEN, AFTER FILLING, THE MICROCATHETER COULD NOT BE ENTERED. FINALLY, THE MICROCATHETER WAS REPLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED WAS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100373 ↗
• MalfunctionSep 29, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE COILING PROCEDURE WHILE DEVELOPING THE COIL, THE DOCTOR FINDS THE RESISTANCE WHILE PUSHING THE COIL AND THE COIL WAS NOT MOVING. THE DOCTOR TRIED ONE MORE TIME AND AGAIN THERE WAS RESISTANCE FELT WHILE PUSHING THE COIL AND THE DOCTOR HAD TO WITHDRAW THE COIL. RESISTANCE OCCURRED IN THE MIDDLE SECTION OF THE CATHETER. THE CATHETER AND COIL WERE NOT DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH A MAX DIAMETER OF 4.73MM AND A 1.45MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT IS "DOING GOOD" WITH NO SYMPTOMS. THE COIL DID COME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17844736 ↗
• MalfunctionAug 18, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD A DETACHMENT FAILURE. AFTER SEVERAL COIL EMBOLIZATION WERE INSERTED, THE PRODUCT WAS FINALLY USED; A DETACHER WAS USED BUT IT COULD NOT BE DETACHED AND THE DELIVERY WAS BROKEN BUT STILL IT COULD NOT BE DETACHED, WHEN TRIED TO COLLECT AND STARTED TO REMOVED IT, IT WAS ABOUT 1CM ONLY WAS DETACHED WHENIT WAS RETURNED IN THE CATHETER. IT WAS PUSHED IN USING THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN TRIED SEVERAL TIMES TO DETACH WITH THE INSTANT DETACHER. DID NOT TRY WITH ANOTHER INSTANT DETACHER. NO MANUAL ATTEMPTS WERE MADE VIA A HYPOTUBE. 1 MANUAL ATTEMPT WAS MADE. THERE WAS NO ISSUES WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR A RUPTURED, AMORPHOUS ANEURYSM IN THE RIGHT INTERNAL CAROTID-PC. THE MAX DIAMETER WAS 7MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW SPEED WAS NORMAL AND VESSEL TORTUOSITY HAD NO ABNORMALITIES. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ANCILLARY DEVICES: FUBUKI 6F GUIDING CATHETER, PHENOM17 MICROCATHETER, CHIKAI14 GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15255292 ↗
• MalfunctionAug 5, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS STUCK INSIDE THE SHEATH AND BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING (IC-PC) SEGMENT. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT WHEN THE COIL WAS DELIVERED TO THE MICROCATHETER, A STRONG RESISTANCE WAS FELT. WHEN IT WAS REMOVED, THE COIL WAS BROKEN. THERE WERE NO PROBLEMS BEFORE AND AFTER THAT THE COIL WAS INSERTED, SO IT WAS BELIEVED THAT THE PROBLEM WAS WITH THE COIL AND NOT WITH THE MICROCATHETER. THE PATIENT DID NOT EXPERIENCE HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A SYNCHRO GUIDEWIRE AND PHENOM 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180099 ↗
• MalfunctionJun 2, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL COULD NOT BE DETACHED WITH THE FIRST INSTANT DETACHER (ID). THE PUSHER WIRE WAS STUCK IN THE PHENOM 17 CATHETER WHEN TRYING TO PULL IT OUT. THE PATIENT WAS UNDERGOING A CEREBRAL ANEURYSM EMBOLIZATION TREATMENT IN THE ACOM VESSEL. THE ACCESS VESSEL DIAMETER WAS 1.5MM. THE ANEURYSM WAS SACCULAR AND UNRUPTURED. THE MAXIMUM DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 3MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY HAD NO ABNORMALITIES. THE DEVICES WERE PREPARED ACCORDING TO THE PACKAGE INSERT. THE CATHETER WAS FLUSHED AS PER INSTRUCTION PER USE (IFU). AFTER PLACING AXIUM PRIME 3×8, THE INSERTION KNOB WAS PULLED INTO THE PROXIMAL END OF THE PUSHER WIRE ON ID 1¿5 IN ORDER TO DETACH IT, BUT IT COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TO DETACH WITH THE ID TWO TIMES. THE PHYSICIAN TRIED WITH ANOTHER DETACHER AND WAS ABLE TO DETACH IT AT ONCE. NO MANUAL ATTEMPTS WERE MADE VIA THE HYPOTUBE. THERE WAS AN ISSUE WITH THE ID. AFTER DETACHING THE COIL, AN ATTEMPT WAS MADE TO PULL THE PUSHER WIRE, BUT IT COULD NOT BE PULLED OUT. IT WAS STUCK INSIDE THE PHENOM 17. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577320 ↗
• MalfunctionMar 23, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE GUIDE CATHETER WAS IN PLACE, THE NAVIEN 072-115 WAS DELIVERED, AND THE ECHELON 10 AND GUIDE WIRE WERE CHOSEN, THE COIL WAS DELIVERED. AS THE FIRST COIL WAS BEING DELIVERED, THE DISTAL TIP OF THE PUSH TUBE WAS BROKEN. THEREFORE, IT WAS REPLACED WITH THE SAME SPECIFICATION AND MODEL COIL, AND THE COIL WAS DELIVERED AND DETACHED SMOOTHLY. AFTER ANGIOGRAPHY, THE DENSE EMBOLISM WAS FILLED, THE CATHETER WAS WITHDRAWN AND THE OPERATION WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2.5MM NECK DIAM ETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DISTAL END OF THE PUSH TUBE WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863355 ↗
• MalfunctionDec 14, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE PUSHED OUT OF THE INTRODUCER SHEATH AND WAS REPLACED. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL DID NOT COME OUT FROM THE INTRODUCER SHEATH, SO HYDRATION WAS NOT POSSIBLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005580 ↗
• MalfunctionOct 19, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE COIL PREMATURELY DETACHED IN THE CATHETER INTRAOPERATIVELY, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT OR INJURY. THERE WAS A LITTLE RESISTANCE WHEN THE COIL WAS PUSHED OUT OF THE INTRODUCER SHEATH, AND IT WAS NOT SMOOTH. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PHENOM CATHETER OR THE COIL PUSHWIRE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED DURING THE PROCEDURE. THERE HAD BEEN NO ATTEMPTS TO DETACH THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661934 ↗
• MalfunctionAug 27, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT A NON-MEDTRONIC COIL WAS FIRST BEING USED BUT THE SURGICAL TEAM REALIZED DURING DELIVERY OF THE COIL THAT THEY DID NOT HAVE A DETACHER FOR THAT COIL SO IT WAS REMOVED AND DISCARDED. THE PREVIOUSLY REPORTED EVENTS THEN OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378208 ↗
• MalfunctionApr 17, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE PROFESSOR PUT THE AXIUM COIL INTO THE MICROCATHETER, THERE WAS RESISTANCE. AFTER REMOVING THE COIL, IT WAS FOUND THE COIL WAS STRETCHED AT THE IMPLANT COIL. IT WAS NOTED THERE WAS NO REPOSITIONING OF THE COIL PERFORMED, AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS NO PATIENT INVOLVEMENT REPORTED WITH THE EVENT. ANCILLARY DEVICES INCLUDE A 6F ENVOY GUIDECATHETER, SL-10 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THE COIL PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND RESISTANCE OCCURRED IN THE PROXIMAL PART OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683123 ↗
• InjuryJul 7, 2020Separation Failure; Detachment of Device or Device Component; Unintended Movement; Separation Failure; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM PRIME COIL DID NOT DEPLOY CORRECTLY, AND MULTIPLE DETACHMENT ATTEMPTS WERE MADE TO DETACH THE COIL. THE EXACT NUMBER OF DETACHMENT ATTEMPTS IS UNKNOWN. THE COIL WOULD NOT DETACH WITH THE DETACHER OR BY BREAKING THE END. WHILE TRYING TO REMOVE THE DEVICE, THE COIL DEPLOYED HALF OUT OF THE ANEURYSM. ULTIMATELY, A STENT WAS USED TO CAGE/TRAP THE DANGLING COIL. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). IT IS UNKNOWN IF THE INSTANT DETACHER HAD OTHER ISSUES. NO IMAGES ARE AVAILABLE. NO PATIENT SYMPTOMS WERE REPORTED. THIS EVENT OCCURRED DURING AN ANEURYSM COILING PROCEDURE. THE BLOOD FLOW AND VESSEL ANATOMY INFORMATION HAS BEEN REQUESTED BUT UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10242702 ↗
• InjuryOct 31, 2019Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE COIL SNAPPED OFF IN THE MICROCATHETER WHEN HALF-DEPLOYED INTO THE ANEURYSM. HALF OF THE COIL REMAINED IN THE PARENT ARTERY REQUIRING STENT PLACEMENT. IT WAS REPORTED THAT RESISTANCE AND STRETCHING HAD BEEN EXPERIENCED DURING DELIVERY OF THE COIL. THE PATIENT WAS UNDERGOING COILING TREATMENT FOR A RUPTURED SACCULAR ANTERIOR COMMUNICATING ARTERY. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9264755 ↗
• MalfunctionApr 8, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THREE IMPLANT COILS HAD DETACHMENT FAILURES WHEN USING THE INSTANT DETACHER (ID-1). THE AXIUM 1X3 AND 2.5X6 WERE DETACHED SMOOTHLY UPON USING THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE); HOWEVER, THE AXIUM 1.5X4 COULD NOT BE DETACHED BY THE MANUAL METHOD. THE COIL WAS THEN PULLED BACK INTO THE MICROCATHETER FOR REMOVAL AND SUDDENLY DETACHED INSIDE THE MICROCATHETER IN THE PROCESS. THE PUSHWIRE WAS REMOVED FROM THE MICROCATHETER AND A 0.001 GUIDEWIRE WAS INSERTED INTO THE SAME MICROCATHETER TO PUSH THE DETACHED COIL INTO THE ANEURYSM AS INTENDED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A 7MM ANEURYSM IN VASCULATURE THAT WAS MEDIUM IN TORTUOSITY. IT WAS NOTED THAT THE COILS WERE PERFORMED WITH FLUSHING TO AIR FLUSH AND THERE WAS NO RESISTANCE AT THE TIME OF INSERTION; HOWEVER, THE BREAK INDICATOR CUT WORSE THAN BEFORE AND DID NOT FEEL RIGHT DURING THE PROCESS OF DETACHMENT USING THE MANUAL METHOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490204 ↗
• MalfunctionApr 1, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THIRD IMPLANT COIL COULD NOT BE DETACHED (THE PREVIOUS TWO COILS WERE SUCCESSFULLY IMPLANTED) WITH THE INSTANT DETACHER DESPITE SEVERAL ATTEMPTS. IT COULD ALSO NOT BE DETACHED WITH THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE). THE HYPOTUBE WAS BROKEN AT THE BREAK INDICATOR AND ON THE DISTAL SIDE AND THE RELEASE WIRE WAS PULLED, BUT THE IMPLANT COIL STILL WOULD NOT DETACH. FINALLY, THE PHYSICIAN DECIDED TO REMOVE THE COIL AND THE IMPLANT COIL SUDDENLY DETACHED DURING RETRIEVAL. THE DETACHED COIL WAS PUSHED INTO THE ANEURYSM WITH THE PUSHWIRE. THE OUTCOME OF THE EVENT WAS UNKNOWN. THE DELIVERY PUSHER WAS NOT ROTATED DURING PROCEDURE. THERE WAS NO DIFFICULTY OR FRICTION DURING PROCEDURE. IT IS UNKNOWN IF THE COIL WAS REPOSITIONED. IT IS UNKNOWN IF THE COIL WAS PLACED IN THE INTENDED LOCATION. THE COIL IS IN THE PATIENT, THE INSTANT DETACHER WORKED WITHOUT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8471432 ↗