AxiumTM APB-2-4-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536021006), received between Jan 28, 2019 and May 13, 2026 — classified as 4 injuries, 8 malfunctions.

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

• MalfunctionMay 13, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED RIGHT ANTERIOR COMMUNICATING ARTERY (ACA) ANEURYSM WITH A MAX DIAMETER OF 6 MM AND A 2.3 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE SUBJECT PRODUCT WAS USED FOR THE FOURTH COIL. EMBOLIZATION WAS COMPLETED AND DETACHMENT WAS PERFORMED WITH INSTANT DETACHER ID1, BUT IT DID NOT DETACH AND AN EVENT OCCURRED IN WHICH THE COIL CAME BACK ATTACHED TO THE DELIVERY WIRE, WHICH IT LED A POOR DISLODGEMENT. A SECONDARY DETACHMENT AT HAND WAS ATTEMPTED BUT THERE WAS NO CHANGE AND DETACHMENT DID NOT OCCUR, SO THE ENTIRE COIL WAS RE-SHEATHED INTO THE PHENOM17MICROCATHETER (MC) AND RETRIEVED TOGETHER WITH THE MC. THE FIRST TO THIRD AXIUM COILS WERE DETACHED WITH THE SAME ID1, SO THE PHYSICIAN JUDGED THAT THIS WAS NOT AN ID1 MALFUNCTION. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER FIVE OR MORE TIMES WITHOUT SUCCESS. NO ATTEMPT WAS MADE TO WITHDRAW OR DETACH THE COIL USING ANOTHER INSTANT DETACHER. A MANUAL REMOVAL ATTEMPT VIA THE HYPOTUBE WAS PERFORMED ONCE. ADDITIONAL INFORMATION WAS RECEI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166366 ↗
• MalfunctionDec 15, 2025Therapy Delivered to Incorrect Body Area; Separation Failure; Detachment of Device or Device Component; Therapy Delivered to Incorrect Body Area; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSES OF BOTH THE NON-DETACHMENT AND THE SUBSEQUENT DETACHMENT AFTER NON-DETACHMENT WERE UNKNOWN. THERE WAS NO PARTICULAR KINK OR DAMAGE OBSERVED ON THE PUSHWIRE. THE INSTANT DETACHER USED HAD A LOT NUMBER OF D057999. NO ISSUES WERE ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT, AND NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23808347 ↗
• InjuryApr 9, 2024Separation Failure; Detachment of Device or Device Component; Unintended Movement; Separation Failure; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURLY DETACHED FROM NON DETACHMENT. AFTER INSERTING THE PRODUCT INTO THE ANEURYSM IN A PATIENT WITH A SUBARCHNOID HEMORRHAGE (SAH), THE ATTEMPTED TO DETACH THE PRODUCT WITH THE CORRESPONDING ID-1-5, BUT THE WITHDRAWAL WAS NOT COMPLETED. WHEN A SECOND WITHDRAWAL FAILED, EARLY DETACHMENT OCCURRED DURING ATTEMPTS TO RETRIEVE IT. THROMBOSIS OCCURRED, BUT IT WAS OVERCOME WITH MEDICATION AND OTHER MEANS. THE COIL WAS ATTACHED TO THE BLOOD VESSEL WITH A STENT. THE COIL WAS PLACED AND ADHERED TO THE BLOOD VESSEL USING A STENT. THE COIL REMAINS IN PATIENT. IT IS NOT PLACED AT THE INTENDED LOCATION. MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO DAMAGE OR DEFORMATION TO THE DELIVERY PUSHER. THERE WAS NO RESISTANCE DURING DELIVERY. THE COIL WAS REPOSITIONED 1 TIME. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL 3 TIMES WITH THE INSTANT DETACHER. THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM IN THE INTERNAL CAROTID CAVE 5MM. THE MAX DI AMETER WAS 5M

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 19076463 ↗
• MalfunctionJan 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL GOT STUCK INSIDE OF THE MICROCATHETER. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A SL-10 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE MIDDLE SECTION. 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 18574518 ↗
• InjuryOct 30, 2023Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL PREMATURELY DETACHED AND REMAINS IN THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT 2 PREVIOUS COILS IN ANEURYSM, 3RD COIL STARTED TO DEPLOY WHEN MICROCATHETER KICKED BACK AND COIL DETACHED PREMATURELY. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE DEVICE REMAINS IN THE PATIENT. THE COIL WAS NOT IMPLANTED IN INTENDED LOCATION. THE COIL IS IN THE VESSEL AT A1/A2 JUNCTION. TRIPLE THERAPY INITIATED POST PROCEDURE. 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 NOT TRY TO REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS

  Patient problems: Foreign Body In Patient

  MAUDE report 18030567 ↗
• MalfunctionOct 26, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE BREAK WAS IN THE PROXIMAL SECTION. THE PRODUCT WAS DAMAGED WHEN THE PACKAGE WAS OPENED. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18014264 ↗
• MalfunctionNov 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CAUSE OF THE PREMATURE DETACHMENT WAS UNKNOWN. NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) WERE MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820088 ↗
• InjuryAug 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THREE COILS PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY SIPHON. THE MAX DIAMETER WAS 12.3MM, AND THE NECK DIAMETER WAS 8.3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS A LOT OF RESISTANCE WHEN THE SPRING COIL (FC-12-40-3D) WAS PUSHED FROM THE PROTECTIVE SHEATH INTO THE MICROCATHETER. THE SURGEON WITHDREW THE DELIVERY GUIDE WIRE AND PLANNED TO TAKE OUT PART OF THE SPRING COIL FOR OBSERVATION. AFTER THE DELIVERY GUIDE WIRE WAS WITHDRAWN FROM THE MICROCATHETER, IT WAS FOUND THAT IT WAS DETACHED AND THE COIL BODY REMAINED IN THE MICROCATHETER. THE COIL WAS REMOVED WITHOUT FURTHER INTERVENTION. THE PUSHWIRE WAS NOT BENT/BROKEN, THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENTS HAD BEEN MADE, AND THE DELIVERY PUSHER WAS NOT ROTATED. DURING THE PROCESS OF FILLING THE ANEURYSM WITH ANOTHER SPRING COIL (FC-8-20-3D), THE SURGEON TRIED TO ADJUST THE POSITION OF THE SPRING COIL INTO THE LOOP. DURING ADJUSTMENT, IT WAS FOUND THAT THE SPRING COIL WAS DETACHED. AT THIS TIME, PART OF THE SPRING COI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15218022 ↗
• InjuryAug 6, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED CONTINUOUSLY DURING THE PROCEDURE. THE AXIUM PRIME 3D 3X6 COIL WAS USED TO STARTED THE COIL EMBOLIZATION. DEPLOYMENT OF THE COIL BEGAN NORMALLY WITHOUT ISSUE. THE PHYSICIAN MANIPULATED THE COIL, PUSHING AND PULLING THE COIL PUSHWIRE, WITHOUT ISSUE. AFTER ABOUT 3CM OF THE COIL WAS DEPLOYED, THE COIL WAS NOT RESPONDING TO PULLING ON THE PUSHWIRE ANYMORE AND IT WAS THOUGHT THE COIL MAY HAVE DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN DECIDED TO CONTINUE WITH DEPLOYMENT BY PUSHING THE COIL, SINCE MOST OF THE COIL WAS ALREADY WITHIN THE ANEURYSM. ONE OF THE LAST LOOPS OF THE COIL WAS DEPLOYED OUTSIDE THE ANEURYSM IN THE MIDDLE CEREBRAL ARTERY (MCA) BRANCH. THE PROCEDURE WAS CONTINUED WITH AN AXIUM PRIME HELIX 2X4  COIL. SLIGHT FRICTION WAS NOTED WHILE DELIVERING THROUGH THE DISTAL END OF THE CATHETER BEFORE THE COIL EXITED THE MICROCATHETER. DELIVERY WAS CONTINUED AND THE COIL DEPLOYED NORMALLY. HOWEVER, IT WAS NOTED THAT ONE LOOP RUPTURED THE ANEURYSM LEADING TO SUBARACHNOID HEMORRHAGE (SAH). THE PHYSICIAN FELT THE 2X4 COIL DID NOT CAUSE

  Patient problems: Intracranial Hemorrhage; Ischemia; Rupture

  MAUDE report 12288296 ↗
• MalfunctionSep 8, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS FAILED TO DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE BATOP 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 MODERATE. IT WAS REPORTED THAT AN SL-10 MICROCATHETER WAS PLACED, AND THE COIL RECANALIZATION PROCEDURE WAS PERFORMED. TWO AXIUM COILS EXPERIENCED THE SAME NON-DETACHMENT ISSUES. THE COILS WERE ATTEMPTED TO BE DETACHED FIVE TIMES WITH THE INSTANT DETACHER, BUT IT FAILED. ANOTHER INSTANT DETACHER WAS NOT USED, THE MANUAL DETACHMENT METHOD WAS PERFORMED TWICE, BUT THE COILS STILL DID NOT DETACH. IT WAS STATED THERE WERE NO ISSUES WITH THE INSTANT DETACHER, AND THE COILS WERE THEN RETRIEVED WITHOUT FURTHER ACTIONS. DETACHMENT OF COILS WAS SUCCESSFULLY DONE BEFORE AND AFTER THE ISSUE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10505216 ↗
• MalfunctionJul 31, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10350950 ↗
• MalfunctionJan 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT WHEN THE AXIUM WAS ADVANCE, IT PREMATURELY DETACHED. A SL-10 CATHETER WAS USED. THE COIL WAS NOT IMPL ANTED IN THE PATIENT. THE LOCATION OF THE COIL IS UNKNOWN BUT THE PUSHWIRE WILL BE RETURNED FOR ANALYSIS. NO MEDICAL INTERVENTION WAS REQUIRED. THE PUSHIWRE DID NOT BREAK. THERE WAS NO FRICTION OR DIFFICULTY WHEN DELIVERING IT. THE COIL WAS NOT REPOSITIONED. THE COIL WAS NOT ATTEMPTED TO BE DETACHED. THE PUSHWIRE WAS NOT ROTATED. A CONTINUOUS FLUSH WAS MAINTAINED. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS EVENT OCCURRED DURING THE TREATMENT OF AN ACOM, UNRUPTURED ANEURYSM THAT WAS SACCULAR. THE MAX DIAMETER WAS 3MM AND THE NECK WAS 2MM. THE BLOOD FLOW AND THE VESSEL TORTUOSITY WERE BOTH NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282717 ↗