AxiumTM APB-3-10-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536021105), received between Apr 4, 2019 and Apr 22, 2026 — classified as 2 deaths, 11 malfunctions.

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

• MalfunctionApr 22, 2026Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 12 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS ORDINARY AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS A COMPLAINT THAT THE RESISTANCE WAS STRONG WHEN REPLACING THE SHEATH WITH A CATHETER IN ORDER TO INSERT THE COIL. AFTER COLLECTING THE COIL AND FLUSHING IT, AN ATTEMPT WAS MADE TO INSERT IT AGAIN, BUT IT WAS THE SAME AS BEFORE. FROM THE HAND MOVEMENT, IT APPEARED HEAVY, AND ALTHOUGH THERE WAS NO BENDING AND ETC. IN THE DELIVERY WIRE, IT WAS THOUGHT TO BE SOME KIND OF MALFUNCTION, SO IT WAS REQUESTED TO BE COLLECTED. IT WAS CONFIRMED THAT THE COIL WAS DISLODGED EARLY IN THE VICINITY OF THE Y-CONNECTOR WHEN IT WAS RETURNED TO THE SHEATH. THE COIL AND DELIVERY WIRE WERE COLLECTED AS A SET. THE COIL WAS REMOVED FROM THE BODY. THERE WERE NO ADDITIONAL SURGICAL OR MEDICAL PROCEDURES PERFORMED. THERE WAS NO DEFORMATION OR DAMAGE TO THE DELIVERY PUSHER. THERE WAS RESISTANCE DURING DELIVERY. THERE WAS COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953701 ↗
• MalfunctionJan 14, 2026Separation Failure; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO KNOWN ISSUES THAT RESULTED IN THE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24076491 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE IN THE MICROCATHETER DURING DELIVERY AND DETACHED PREMATU RELY. IT WAS REPORTED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. DURING DELIVERY OF THE COIL, THERE WAS RESISTANCE AT THE MIDDLE SECTION OF THE MICROCATHETER. WHEN THE COIL WAS PULLED BACK, IT DETACHED PREMATURELY. THE COIL AND MICROCATHETER WERE RETRIEVED THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS KINK/DAMAGE TO COIL PUSHWIRE. THERE WAS NO IMPACT TO THE PATIENT AND THE BLOOD VESSEL FLOW WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23740797 ↗
• MalfunctionSep 21, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT WHEN THE PRODUCT WAS REMOVED FROM THE HOOP, THE PHYSICIAN WHO WAS THE ASSISTANT PERFORMED THE PREPARATION, AND THERE WAS A POSSIBILITY THAT THE HOOP WAS BENT TO THE ANCHOR POINT BY OPERATING IT WITH A LONG SPAN. AS WITH NORMAL PREPARATION, WHEN THE DELIVERY PUSHER WAS PRESSED TO EXTEND THE COIL IN SALINE IN ORDER TO VISUALLY CHECK FOR DAMAGE AND TO CONFIRM THE COIL'S CONNECTION, IT WAS ALREADY DISCONNECTED SO IT WAS BELIEVED THAT THERE WAS NO DETACHMENT ATTEMPT. THE CATHETER USED WAS AN SL-10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788552 ↗
• MalfunctionMar 10, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL BEGAN TO DEPLOY (BREAK) IN THE GAP BETWEEN THE DISTAL INTRODUCER SHEATH AND MICRO CATHETER HUB. THUS THE COIL BECOMES STUCK AT THE DISTAL INTRODUCER SHEATH. THERE IS NO PATIENT INVOLVED IN THIS EVENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTION FOR USE (IFU).  UPON AXIUM COIL EXITING THE NON-TAPERED COIL INTRODUCER SHEATH AND ENTERING THE TAPERED HUB OF THE MICROCATHETER THE AXIUM COIL BEGAN TO DEPLOY IN THE GAP BETWEEN DISTAL INTRODUCER SHEATH AND MICROCATHETER HUB. THUS THE COIL BECOMES STUCK AT THE DISTAL INTRODUCER SHEATH.  ANCILLARY DEVICES: STRYKER SL-10, LOT#: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13717387 ↗
• MalfunctionJun 8, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO PARTICULAR DAMAGE OBSERVED TO THE COIL PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11958765 ↗
• MalfunctionJan 20, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11201775 ↗
• MalfunctionJan 9, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING A COIL REPLACEMENT, THERE WAS EARLY HIGHLIGHT, AND COIL WAS LOST INSIDE THE PATIENT'S "VASE." IT WAS CLARIFIED THAT THE FOLLOWING OCCURRED: COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL REMAINED IN THE PATIENT AND WAS NOT IMPLANTED AT THE INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID REPOSITION THE COIL BUT DID NOT ATTEMPT TO DETACH IT. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THIS EVENT RESULTED IN NO INJURY TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9570823 ↗
• MalfunctionJul 10, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING THE INSERTION OF THE COIL, IT BECAME DIFFICULT TO BE INSERTED IN THE CENTRAL PART AND DISTAL SIDE OF THE CATHETER, AND WHEN IT WAS PUSHED FURTHER, THE PUSHER/SHAFT BROKE, SO THE USAGE OF THE DEVICE WAS STOPPED. THERE WAS NO DAMAGE TO THE CATHETER. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER MANUFACTURER'S DEVICE, AND THE PROCEDURE WAS CONTINUED. THE PATIENT WAS UNDERGOING TREATMENT FOR ARTERIOVENOUS MALFORMATION OR ARTERIOVENOUS FISTULA, AND THE LESIONS WERE NOT LOCATED IN THE ELOQUENT AREA OF THE BRAIN. IT WAS NOTED THE VESSEL TORTUOSITY WAS MINIMAL. IT WAS CONFIRMED THAT THE COIL CAME SMOOTHLY FROM THE INTRODUCER SHEATH. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED/FLUSHED/HYDRATED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A STRYKER SL10 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8777012 ↗
• MalfunctionJun 2, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED WITH INSTANT DETACHER DURING TREATMENT OF AN SUBARACHNOID HEMORRHAGE (SAH) AND A NEW INSTANT DETACHER WAS USED TO DETACH THE COIL WITHOUT ANY ISSUES. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE INSTANT DETACHER WAS ATTEMPTED 2 ¿ 3 TIMES WITHOUT SUCCESS. THE SECOND INSTANT DETACHER WAS USED ONCE AND IT DETACHED. THERE WAS NOT ANYTHING IN PARTICULAR DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THE PATIENT WAS UNDERGOING EMBOLIZATION OF A RUPTURED AMORPHOUS ANEURYSM MEASURING 8MM (DIA) X UNKNOWN NECK LOCATED IN THE LEFT IC-PC. THE BLOOD FLOW WAS NORMAL AND THE VASCULATURE WAS NORMAL IN TORTUOSITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8661374 ↗
• MalfunctionMay 31, 2019Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL STRETCHED AFTER IT WAS INSERTED INTO THE MICROCATHETER. IT WAS ALSO NOTED THAT THERE WAS DAMAGE/PREMATURE DETACHMENT. AS A RESULT THE DEVICE WAS REMOVED. THE DEVICE WAS PREPARED PER THE IFU. THERE WAS NO DAMAGE TO THE PUSHER, NOR WAS THERE RESISTANCE AT THE TIME OF DELIVERY. THE COIL WAS NOT REPOSITIONED AND NO ATTEMPT WAS MADE TO DETACH THE COIL. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658784 ↗
• DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.

  Patient problems: Death

  MAUDE report 8483829 ↗
• DeathApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT OF PATIENT DEATH AFTER COILING. THE PATIENT PRESENTED WITH HEMORRHAGE. THE PATIENT HAD A RUPTURED, SACCULAR ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT COILING IN ORDER TO IMPROVE THE SITUATION. THE PATIENT UNDERWENT IMPLANTATION OF 13 COILS INCLUDING 9 MEDTRONIC COILS. THE PATIENT REPORTEDLY PASSED AWAY POST-PROCEDURE DUE TO THE MASSIVE HEMORRHAGE.

  Patient problems: Death

  MAUDE report 8483771 ↗