AxiumTM APB-3.5-8-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536021266), received between Jan 10, 2019 and Oct 6, 2023 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES ENCOUNTERED PRIOR TO COIL NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886797 ↗
• MalfunctionSep 18, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES ENCOUNTERED PRIOR TO COIL NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770006 ↗
• MalfunctionJun 30, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT AFTER ABOUT 1/3 OF THE COIL WAS DEPLOYED, THE SURGEON COULD NOT ADVANCE IT ANYMORE. THE SURGEON PULLED THE COIL BACK INTO THE CATHETER AND REMOVED THE COIL. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR BASILAR ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN DROP THE COIL ABOUT 1/3 COIL, DOCTOR CAN'T PUSH ANYMORE. HE PULLED THE COIL BACK TO THE CATHETER AND PULLED OUT THE COIL. COIL RESISTANCE/STUCK IN CATHETER WAS NOTED. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. IT WAS NOTED THAT THE COIL WAS REMOVED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237999 ↗
• MalfunctionSep 1, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL EXPERIENCED STRONG RESISTANCE IN THE CENTRAL PART OF THE MICROCATHETER. WHEN THE COIL WAS COLLECTED IT WAS FOUND TO BE BROKEN. 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 15342138 ↗
• MalfunctionSep 16, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS DIFFICULT TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A 4MM NECK DIAMETER. THE ANEURYSM WAS IN THE RIGHT INTERNAL CAROTID ARTERY - POSTERIOR COMMUNICATING ARTERY (IC-PC). IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMALAND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THEY USED 7F LOAD MASTER AND 4.2F FUBUKI, APPROACHED THE SL10 TO THE DOME PART OF THE ANEURYSM USING A SIMPLE T ECHNIQUE AND STARTED COILING. FOR THE SECOND DEVICE (THE REPORTED PRODUCT), WHEN TRYING TO DETACH THE COIL AFTER PLACING IT, IT COULD NOT BE DETACHED, SO THE DETACHER WAS REPLACED. HOWEVER, IT ALSO COULD NOT BE CUT, SO IT WAS TRIED TO MANUALLY DETACH, BUT IT COULD NOT BE CUT, SO THE COIL WAS ATTACHED WITHOUT BEING DETACHED. WHEN THE DELIVERY WIRE WAS PULLED A LITTLE TO ATTEMPT TO RETRIEVE THE PRODUCT, THE COIL WAS DETACHED IN A HALFWAY POSITION. AFTER THAT, THEY PUSHED IT WITH A WIRE AND THERE WAS NO PROBLEM, BUT THEY THOUGHT THE PRODUCT HAD A DEFECT. THE DOCTOR ATTEMPTED TO DETACH THE COIL USING AN INSTANT DETACHER 3 TIMES. THE DOCTOR ATTEMPTED TO DETACH THE COIL USING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482442 ↗
• MalfunctionJul 20, 2021Detachment of Device or Device Component; Material Deformation; Packaging Problem; Detachment of Device or Device Component; Material Deformation; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. A KINK WAS NOTICED WHEN THEY TOOK THE PUSHER OUT OF THE HOOP. SINCE THE COIL WAS ALREADY DETACHED AT THE TIME OF PREPARATION, DETACHMENT BY THE DETACHER WAS NOT PERFORMED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197692 ↗
• MalfunctionFeb 17, 2021Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AM UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT MCA BIFURCATION. THE MAX DIAMETER WAS 5.7MM. THE NECK DIAMETER WAS 2.3MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN DEPLOYING THE DEVICE, THE COIL WAS DETACHED IMMEDIATELY INSIDE THE MICROCATHETER BEFORE COMPLETE DETACHMENT IN THE ANEURYSM WALL. THE PHYSICIAN HAD NOT ATTEMPTED TO DETACH THE COIL. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD NOT BEEN ANY FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL, AND A CONTINUOUS FLUSH WAS ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN ENVOY GUIDE CATHETER, ECHELON 10 MICROCATHETER, AND AVIGO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11338782 ↗
• MalfunctionOct 21, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN ATTEMPTED TO DETACH THE AXIUM COIL THREE TIMES WITH THE INSTANT DETACHER, BUT THE COIL FAILED TO DETACH. THE MANUAL DETACHMENT METHOD WAS THEN ATTEMPTED, BUT THE COIL STILL DID NOT DETACH. THE PUSHWIRE WAS THEN PULLED FOR RETRIEVAL, AND THE COIL DETACHED DURING RETRIEVAL. THE COIL WAS CAUGHT IN THE STENT AND RETRIEVED TOGETHER WITH THE STENT. THE DOCTOR CONSIDERED THE EVENT TO BE A COIL ISSUE. REPLACEMENT PRODUCTS WERE USED TO COMPLETE 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) ARTERY WITH A MAX DIAMETER OF 4 MM AND A 2.3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10714453 ↗
• MalfunctionJul 3, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME BARE (APB) COIL EXPERIENCED RESISTANCE AND PREMATURELY DETACHED IN THE CATHETER HUB, AND ANOTHER HELIX COIL ALSO EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE APB COIL ADVANCED FROM THE SHEATH TO THE CATHETER EASILY INITIALLY, BUT SOON A TIGHT RESISTANCE WAS FELT. THE DOCTOR TOOK THE COIL BACK INTO THE SHEATH BUT NOTICED IT HAD DETACHED PREMATURELY IN THE HUB. A COIL FROM ANOTHER MANUFACTURER WAS DELIVERED WITHOUT ISSUE AFTERWARDS, BUT THEN A HELIX COIL WAS ATTEMPTED WHICH ALSO EXPERIENCED RESISTANCE AFTER FREELY MOVING INTO THE MICROCATHETER. THE DOCTOR FELT THE RESISTANCE WAS TOO HIGH, SO ANOTHER HELIX COIL WAS USED WHICH DEPLOYED SMOOTHLY. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PUSHWIRE WAS NOT BENT OR BROKEN, AND WAS NOT ROTATED IN THE PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4 MM. THE NECK DIAMETER WAS 2.7 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A PE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10228427 ↗
• MalfunctionSep 12, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER INSERTING THE COIL, DETACHMENT WAS ATTEMPTED USING THE INSTANT DETACHER WHICH FAILED. A MANUAL DETACHMENT METHOD WAS ATTEMPTED, BUT WHEN THE DELIVERY PUSHER WAS PULLED THE COIL FOLLOWED AND COULD NOT BE DETACHED. AFTER PUSHING AND PULLING THE PUSHER SEVERAL TIMES, THE COIL DETACHED IN THE ANEURYSM SUCCESSFULLY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, AMORPHOUS VERTEBRAL ARTERY WITH A MAX AND NECK DIAMETER OF 5MM. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. 3 ATTEMPTS WERE MADE USING THE INSTANT DETACHER, ONE ATTEMPT USING MANUAL DETACHMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9008655 ↗
• MalfunctionJun 9, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH WHEN THE DETACHMENT ATTEMPT WAS MADE WITH THE INSTANT DETACHMENT (ID). THE COIL WAS RETRIEVED. ONCE OUTSIDE THE PATIENT, THE COIL UNINTENTIONALLY DETACHED. THE SAME ID WAS ABLE TO DETACH THE REPLACEMENT COIL WITHOUT ANY ISSUES. THE CUSTOMER WAS NOTIFIED THAT THE PRODUCT SHOULD BE RETURNED. THE REPORTED DEVICE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8681401 ↗
• MalfunctionJan 10, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM IMPLANT COIL COULD BE DETACHED WITH THE INSTANT DETACHER AND ALSO COULD NOT BE DETACHED USING THE MANUAL METHOD (ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE). THE DELIVERY PUSHER WAS REPEATEDLY PUSHED AND PULLED BIT BY BIT AND THEY MANAGED TO DETACH THE IMPLANT COIL SOMEHOW. NO PATIENT INJURY AS REPORTED AS A RESULT OF THE EVENT. THE DETAILS OF THE PATIENT¿S VASCULATURE AND ANEURYSM WERE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8236221 ↗