Axium Prime Detachable Coil System APB-2-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000313685), received between Feb 28, 2022 and Feb 6, 2026 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME BARE COIL WAS SELECTED FOR FINISHING. AFTER ADVANCING THE COIL INTO THE ANEURYSM, MULTIPLE ATTEMPTS AT DETACHMENT WERE UNSUCCESSFUL. THE COIL WAS WITHDRAWN, BUT DETACHMENT OCCURRED DURING RETRIEVAL. THE ENTIRE COIL WAS THEN REMOVED FROM THE PATIENT'S BODY, AND A NEW MEDTRONIC COIL WAS USED INSTEAD TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING STENT-ASSISTED COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, MIDDLE CEREBRAL ARTERY ANEURYSM 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 MINIMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER OR ANOTHER INSTANT DETACHER. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. TWO MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE WERE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280016 ↗
• MalfunctionJan 29, 2026Material Deformation; Packaging Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PUSHER WAS KINKED AFTER REMOVING FROM THE PACKAGE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM LOCATED IN THE INTERNAL CAROTID ARTERY OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 4.6 MM AND A 3.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER TAKING THE AXIUM COIL OUT OF THE PACKAGING, IT WAS FOUND THAT THE PUSHER ROD WAS KINKED, AND THE BENDING ANGLE WAS SIGNIFICANT. AS A RESULT, IT COULD NOT BE SMOOTHLY ADVANCED INTO THE MICROCATHETER, AND THE DELIVERY OF THE COIL WAS AFFECTED. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATION WAS THE PUSHWIRE MIDDLE SEGMENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SPRING COIL WAS NOT USED AFTER IT WAS DISCOVERED TO BE KINKED. NO PREPARATION WAS COMPLETED TO THE DEVICE AS DAMAGE WAS DISCOVERED AS SOON AS THE PACKAGING WAS OPENED. THE PROCEDURE WAS COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218621 ↗
• MalfunctionOct 30, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO ECHELON 10 45° PRE-SHAPED TIP MICROCATHETERS WERE OBSERVED WITH DISTAL END DAMAGE UPON SHAPING AND RESISTANCE WAS ENCOUNTERED WITH AN AXIUM PRIME BARE 3D COIL. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR INTERNAL CAROTID ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. ARTERIAL ACCESS WAS GAINED VIA THE FEMORAL ARTERY. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETERS WERE FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER MICROCATHETER SHAPING, THE DISTAL END OF THE MICROCATHETERS WERE FOUND TO BE DAMAGED. THEY WERE REPLACED WITH A NEW MEDTRONIC CATHETERS. ADDITIONALLY, AN AXIUM COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. IT WAS REPLACED WITH A NEW MEDTRONIC COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ASIDE FROM FLUSHING AND SHAPING, NO OTHER ACTION HAD BEEN TAKEN PRIOR TO THE DAMAGE BEING OBSERVED. THE CAUSE OF THE DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430405 ↗
• MalfunctionOct 17, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23328243 ↗
• MalfunctionMay 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE/WAS STUCK IN THE THE SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A MIDDLE CEREBRAL ARTERY (MCA) RUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 2.5MM AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE AXIUM PRIME BARE 3D 2MM X 3CM EXTRA SOFT COIL. RESISTANCE WAS FELT IN SHEATH WHEN PUSHING THE COIL INTO THE MICROCATHETER. THE COIL WAS PULLED BACK AND ANOTHER ATTEMPT WAS MADE AT DELIVERY, BUT THE RESISTANCE PERSISTED. THE PHYSICIAN DECIDED TO USE ANOTHER MANUFACTURER'S COIL OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THERE WAS NO DAMAGE OBSERVED TO THE AXIUM COIL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009564 ↗
• MalfunctionMar 31, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL SEPARATED/BROKE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 4.1MM AND A 3.4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE COIL IMPLANTATION PROCESS, THE COIL TIP WAS FOUND TO HAVE FALLEN OFF AND COULD NOT BE IMPLANTED. THE COIL WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. 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 REPOSITION THE COIL OR ATTEMPT TO DETACH. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. 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 COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21730149 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT ON DECEMBER 16 (MONDAY), TREATMENT WAS PERFORMED FOR AN UNRUPTURED ANEURYSM WITH AN IC OF 6-7 MM. PREOPERATIVE PLAN WAS AFTER PLACING 2 COILS WITH BALLOON ASSIST, THE MICROCATHETER WILL BE REPLACED AND THE PIPELINE WILL BE PLACED. THE RIST WAS SUCCESSFULLY GUIDED SMOOTHLY TO THE VICINITY OF THE CAVERNOUS AREA. AN ATTEMPT WAS MADE ABOUT 3 TIMES TO ACCESS THE ANEURYSM, AND THE MICROCATHETER WAS SUCCESSFULLY PLACED IN THE ANEURYSM. ONE APB-3-8-3D AND ONE APB-3-6-3D WERE PLACED WITH BALLOON ASSIST. UPON PERFORMING A CONTRAST IMAGING USING THE RIST, DECREASED PERIPHERAL BLOOD FLOW WAS FOUND (PERIPHERAL FROM M3). HEALTHCARE PROVIDER (HCP) COMMENTED THAT THERE WAS A POSSIBILITY THAT A THROMBUS MIGHT HAVE RELEASED WHEN INDUCED TO AN ANEURYSM USING THE MICROCATHETER. PIPELINE PLACEMENT WAS DISCONTINUED AT THE DISCRETION OF THE HCP. RE-TREATMENTIS SCHEDULED AT A LATER DATE AFTER RECOVERY OF BLOOD FLOW. 2 APB-2-3-3D WERE ADDED, AND THE PROCEDURE WAS COMPLETED. ON MARCH 10 (MONDAY), IT WAS REPORTED THAT A PATIENT IN 40S DEVELOPED A HIGH-LEVEL FUNCTIONAL DISORDER. DETAILS ARE UNKNOWN, BUT THE SYMPTOMS ARE SPEECH IMPAIRMENT AND LOWER HALF OF THE BODY PARALYSIS. T

  Patient problems: Air Embolism; Dysphasia; Nervous System Injury; Paralysis; Reduced Blood Flow

  MAUDE report 21634690 ↗
• MalfunctionJan 13, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A RUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY, THE AXIUM PRIME BARE 3D 2MM X 3CM EXTRA SOFT COIL EXPERIENCED RESISTANCE AND BECAME STUCK IN THE SHEATH. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 3 MILLIMETERS AND A NECK DIAMETER OF 1 MILLIMETER, WITH MODERATE VESSEL TORTUOSITY AND NORMAL BLOOD FLOW. THE MICROCATHETER USED WAS AN ECHELON. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DETACHMENT ATTEMPTS WERE MADE. THE COIL ACCIDENTALLY BROKE DURING PROCEDURE. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. IT WAS UNKNOWN IF THE COIL PREMATURELY DETACH IN THE CATHETER. THE PATIENT WAS BEING FOLLOWED UP WITH CLOSELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21145980 ↗
• MalfunctionNov 3, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO DETACHMENT ATTEMPTS. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS REMOVED FROM THE PATIENT. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064488 ↗
• InjuryMay 4, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE DETACHMENT POINT REACHED THE DETACHMENT ZONE, THEY MANUALLY DETACHED THE COIL. THEY WITHDREW THE PUSH ROD, AND FOUND THAT THE COIL WAS NOT DETACHED. THEY REPEATEDLY ADJUSTED THE POSITION OF THE MICROCATHETER, PUSH ROD AND COIL FOR HALF AN HOUR BUT IT STILL DID NOT DETACH. THEY DECIDED TO WITHDRAW THE COIL TO VITRO, ON THE WAY TO WITHDRAW, THE COIL DETACHED. THE COIL WENT IN THE BLOOD VESSEL AND RAN TO THE DISTAL OF THE BLOOD VESSEL WITH THE BLOOD FLOW. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT SIDE A1 WITH A MAX DIAMETER OF 5*3MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14274396 ↗
• InjuryFeb 28, 2022Separation Failure; Detachment of Device or Device Component; Migration; Separation Failure; Detachment of Device or Device Component; Migration

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED. AFTER DEPLOYMENT OF THE STENT, THE EMBOLIZATION OF THE COIL WAS SATISFACTORY. AFTER WHAT THEY DETERMINED WAS DETACHMENT OF THE COIL, IT WAS FOUND THE COIL HAD MOVED AND NOT DETACHED. AFTER REPEATEDLY ADJUSTING THE MICROCATHETER AND PUSHING THE GUIDE WIRE FOR TWO HOURS, THE COIL COULD NOT BE DETACHED. THEY DECIDED TO SLOW WITHDRAW THE SYSTEM FROM THE PATIENT AND THE COIL WAS DETACHED WHEN THE COIL WAS RETRACTED INTO THE MICROCATHETER ABOUT 5MM AND THE COIL WAS PUSHED INTO THE TUMOR BY USING THE PUSH GUIDE WIRE. THERE WAS STILL ABOUT 1MM LEFT IN THE BLOOD VESSEL AND THE STENT WAS DETACHED TO PRESS THE COIL TO END THE SURGERY. 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 4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS LOW AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13620977 ↗