AxiumTM APB-1.5-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536021167), received between Dec 12, 2018 and May 21, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR ARTERIOVENOUS MALFORMATIONS OR ARTERIOVENOUS FISTULAS, THE LESION GRADE IS UNKNOWN. THE FOCI WAS NOT LOCATED IN THE FUNCTIONAL AREA OF THE BRAIN (ELOQUENT AREA). IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS SLOW AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING TREATMENT FOR D-AVF, AFTER INSERTING MORE THAN 10 COILS, AN ATTEMPT WAS MADE TO INSERT THE AXIUM COIL A PB-1.5-4-3D-ES; HOWEVER, THE BREAK INDICATOR WAS FOUND TO BE BROKEN, AT THE PROXIMAL PUSHER. THE COIL WAS REPLACED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED 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 25249188 ↗
• MalfunctionDec 9, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AMORPHOUS, RUPTURED EXTERNAL CERVICAL RIGHT ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS USED AND COULD NOT BE DETACHED. IT COULD NOT BE DETACHED EVEN BY FORCE AND WHEN AN ATTEMPT WAS MADE TO COLLECT THE PRODUCT, THE COIL WAS DETACHED AT THE CATHETER HUB. PRIME COIL WAS USED IN THE 11TH DEVICE, AND IT COULD BE DETACHED WITHOUT ANY PROBLEMS, SO IT IS BELIEVED TO BE A PROBLEM WITH THE COIL.  POOR DISLODGEMENT WAS NOTED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER TWO TIMES AND DID NOT ATTEMPT WITHDRAWAL WITH ANOTHER INSTANT DETACHER. ONE MANUAL DISLODGEMENT ATTEMPT WAS MADE THROUGH HYPOTUBE. THE PRESENCE OF ANY DEFECTS WITH THE INSTANT DETACHER IS UNKNOWN. 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. ANCILLARY DEVICES INCLUDE A SYNCHRO GUIDEWIRE, SL10 MICROCATHETER, FUBUKI6F GUIDING CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763968 ↗
• MalfunctionApr 20, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANTERIOR CEREBRAL ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 1MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.  IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER FORMING A HOOP, THE AXIUM COIL (MODEL: APB-1.5-4-3D-ES) WAS SELECTED FOR FILLING. HOWEVER, THE COIL COULD NOT BE DETACHED. AFTER MULTIPLE ATTEMPTS TO DETACH WITHOUT SUCCESS, THE COIL WAS REPLACED WITH ANOTHER THAT WAS USED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14162323 ↗
• MalfunctionJan 5, 2022Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE NORMAL ANGIOGRAPHY WAS OVER, THE ACCESS CATHETER WAS ESTABLISHED. THE FIRST COIL WAS PUSHED IN THE MICRO-CATHETER AND CONTINUED TO FILL, AND THE SECOND COIL WAS IN THE PROCESS OF FILLING BUT IT COULD BE SEEN UNDER THE IMAGE THAT IT WAS STRETCHED IN THE BODY. THE COIL WAS REPLACED AND REFILLED, AND THE OPERATION PROCEEDED SMOOTHLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13173427 ↗
• MalfunctionNov 22, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONE DETACHMENT ATTEMPT WAS MADE WITH THE INSTANT DETACHER, AND ONE ATTEMPT WAS MADE WITH THE MANUAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858623 ↗
• MalfunctionDec 8, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10967878 ↗
• MalfunctionJul 31, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE ECHELON10 MICROCATHETER WAS USED FOR FILLING NORMALLY, AND THE TIP OF THE COIL DETACHED DURING 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) WITH A MAX DIAMETER OF 5.0MM AND A 3.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10351315 ↗
• MalfunctionMay 1, 2020Migration; Migration

  MEDTRONIC RECEIVED THAT DURING THE COILING PROCEDURE, THE FIRST COIL¿S PUSHWIRE WAS ALLEGED TO HAVE BROKEN. WHEN THE SECOND COIL WAS ADVANCED THROUGH THE HEADWAYDUO (COMPETITOR DEVICE) CATHETER RESISTANCE WAS FELT AND THE FIRST IMPLANTED COIL WAS MOVED. THE FIRST AND THE SECOND COIL WERE ALLEGED TO HAVE ENTANGLED. "ACCORDING TO IFU, THE REPORTED PRODUCT WAS PREPARED, AND THE COIL WAS INSERTED THROUGH THE MICROCATHETER. AFTER THE COIL WAS SUCCESSFULLY COMPLETED, IT WAS DETACHED, AND THE DELIVERY SYSTEM WAS RETRIEVED. ALTHOUGH THE DETACHMENT SEEMED TO HAVE BEEN PERFORMED WITHOUT A PROBLEM WITH ALIGNING THE SECOND MARKER, A STRONG RESISTANCE WAS ENCOUNTERED WHEN THE SECOND COIL WAS INSERTED AFTER THE DELIVERY SYSTEM WAS RETRIEVED, AND THE FIRST COIL STARTED TO MOVE WHEN INSERTED WITHOUT ANY ACTION. THE FIRST COIL (BROKEN PRODUCT) AND THE SECOND COIL WERE TANGLED AND MOVED, AND AFTER THE SECOND COIL WAS RETRIEVED ONCE, THE MICROCATHETER WAS RETRIEVED TOGETHER, THE DELIVERY SHAFT OF THE FIRST COIL REMAINED AND IT WAS FOUND THAT IT WAS STRETCHED." THE STRETCHED DELIVERY SYSTEM WAS DIFFICULT TO RETRIEVED, SO IT REMAINED IN THE BODY, THE MICROCATHETER WAS RE-APPROACHED AND THE SECOND COIL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10018128 ↗
• MalfunctionSep 27, 2019Separation Failure; Activation, Positioning or Separation Problem; Unintended Movement; Separation Failure; Activation, Positioning or Separation Problem; Unintended Movement

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL EXPERIENCED DETACHMENT ISSUES. TWO DETACHED ATTEMPTS WERE WITH AN INSTANT DETACHER. NO OTHER DETACHMENT METHODS WERE USED, AND THE COIL FINALLY DETACHED. THE DISTAL TAIL OF THE COIL WAS PULLED OUT WITH MICROCATHETER TIP, FOR A COUPLE MM. THIS EVENT OCCURRED DURING THE TREATMENT OF A BASILAR TIP, UNRUPTURED, SACCULAR ANEURYSM. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY. ANCILLARY DEVICES: SL10, SYNCRHO2.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9130581 ↗
• MalfunctionSep 27, 2019Separation Failure; Activation, Positioning or Separation Problem; Unintended Movement; Separation Failure; Activation, Positioning or Separation Problem; Unintended Movement

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL EXPERIENCED DETACHMENT ISSUES. TWO DETACHED ATTEMPTS WERE WITH AN INSTANT DETACHER. NO OTHER DETACHMENT METHODS WERE USED, AND THE COIL FINALLY DETACHED. THE DISTAL TAIL OF THE COIL WAS PULLED OUT WITH MICROCATHETER TIP, FOR A COUPLE MM. THIS EVENT OCCURRED DURING THE TREATMENT OF A BASILAR TIP, UNRUPTURED, SACCULAR ANEURYSM. THE VESSEL ANATOMY WAS NORMAL IN TORTUOSITY. ANCILLARY DEVICES: SL10, SYNCRHO2.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9130561 ↗
• MalfunctionAug 6, 2019Activation Problem; Activation Problem

  MEDTRONIC RECEIVED INFORMATION THAT THIS COIL STRETCHED WHILE FILLING AN ANEURYSM. THE PHYSICIAN REMOVED THE COIL FROM THE CATHETER. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT FOR A SMALL UNRUPTURED SACCULAR ANTERIOR COMMUNICATING ARTERY ANEURYSM. MEASURING 5.5MMX2.5MM THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS MODERATELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT INJURY WAS REPORTED. THERE WAS NOT ANY FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. YES, THE CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. 6F ENVOY DA, EXCELSIOR-10 45 AND 90, SYNCHRO WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8866421 ↗
• 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 8490181 ↗
• MalfunctionDec 12, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT, WHEN THE INSTANT DETACHER WAS PULLED OUT TO DETACH THE COIL, THE COIL CAME OUT TOGETHER STILL ATTACHED. MULTIPLE ATTEMPTS WERE MADE USING THE INSTANT DETACHER WITHOUT RESOLVE, SO A MANUAL DETACHMENT METHOD WAS PERFORMED, RESULTING IN THE COIL FINALLY DETACHING. IT WAS NOTED THAT THE PHYSICIAN HAS HAD MANY DETACHMENT ERRORS WITH THE COIL TYPE. THE PATIENT WAS UNDERGOING EMBOLIZATION SURGERY FOR TREATMENT OF A 3MM ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD A SLIGHTLY SEVERE VESSEL TORTUOSITY AND A SLIGHTLY SMALL VESSEL TORTUOSITY. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE FUBUKI 6FR, SHOURYU4*7, ECHELON 10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8156633 ↗