Axium Prime Detachable Coil System APB-1-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000313791), received between May 20, 2022 and Sep 24, 2026 — classified as 15 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Unintended Movement; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886464 ↗
• MalfunctionApr 29, 2026Difficult or Delayed Positioning; Stretched; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS USED. THE ADVERSE EVENT (AE) OVERVIEW STATED THAT THE PATIENT EXPERIENCED NO DISCOMFORT AND NO HARM WAS CAUSED AT THAT TIME. THE SITUATION FOR USE SECTION STATED THAT THIS PRODUCT IS SUITABLE FOR EMBOLIZATION TREATMENT OF INTRACRANIAL ANEURYSMS AND OTHER NEUROVASCULAR MALFORMATIONS SUCH AS ARTERIOVENOUS MALFORMATIONS AND ARTERIOVENOUS FISTULAS, AS WELL AS ARTERIAL AND VENOUS EMBOLIZATION TREATMENT OF PERIPHERAL BLOOD VESSELS. THERE WAS STENT PLACEMENT AND ANTIPLATELET THERAPY (ENTERIC-COATED ASPIRIN TABLETS PLUS CLOPIDOGREL TABLETS) USED. THE DEVICE WAS USED ON (B)(6) 2026 IN A MEDICAL INSTITUTION IN THE INTERVENTIONAL ROOM. THE USE PROCESS DESCRIPTION STATED THAT: "1. DESCRIPTION OF USE: ON (B)(6) 2026, THE PATIENT WAS TREATED FOR RUPTURED INTRACRANIAL ANEURYSM WITH HEMORRHAGE. MEDICAL STAFF PERFORMED ANEURYSM EMBOLIZATION USING DETACHABLE COILS WITH STENT ASSISTANCE. POSTOPERATIVE HEAD CT REVIEW REVEALED A LINEAR HIGH-DENSITY SHADOW NEAR THE PROXIMAL END OF THE ANEURYSM, INDICATING PARTIAL DISPLACEMENT OF THE COIL WIRE. THE PATIENT EXPERIENCED NO DISCOMFORT AND NO HARM WAS IDENTIFIED AT THAT TIME. THE PATIENT¿S CONDITION WAS SCHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034060 ↗
• MalfunctionNov 3, 2025Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS BEING TREATED FOR AN IRREGULAR ANEURYSM, APPROXIMATELY 5 MM IN SIZE, IN THE NECK SEGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23450846 ↗
• MalfunctionAug 29, 2025Stretched; Material Deformation; Physical Resistance/Sticking; Stretched; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE AT THE CATHETER HUB AND THE PROXIMAL SECTION WHEN PUSHING THE AXIUM SPRING COIL, AND THE COIL WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE ANTERIOR CEREBRAL ARTERY WITH A MAX DIAMETER OF 2 MM AND A 1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT WHEN THE SURGEON TREATED THE ANTERIOR CEREBRAL MICROANEURYSM, THE SURGEON USED A COIL FOR EMBOLIZATION. WHEN THE COIL WAS PUSHED, THE SURGEON FELT RESISTANCE, SO THEY PULLED THE COIL OUT OF THE BODY FOR OBSERVATION AND FOUND THAT THE COIL WAS STRETCHED. THE IMPLANT PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE CATHETER WAS NOT DAMAGED BUT THE PUSHWIRE DISTAL SEGMENT WAS DAMAGED. THE SURGEON REPLACED IT WITH A NEW COIL AND CONTINUED THE OPERATION. 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. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THERE WERE NO OTHER ISSUES BESIDES THE RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22926848 ↗
• MalfunctionMay 8, 2025Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE CATHETER AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21987754 ↗
• MalfunctionApr 4, 2025Stretched; Stretched

  IT WAS REPORTED THAT DURING AN INTRACRANIAL ANEURYSM EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE INTERNAL CAROTID ARTERY, THE DETACHABLE COIL (APB-1-2-HX-ES) STRETCHED BEFORE IT FILLED INTO THE ANEURYSM. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 6 MILLIMETERS AND A NECK DIAMETER OF 3 MILLIMETERS. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE SURGEON REQUESTED A REPLACEMENT OF THE DEVICE AND RETAINED THE SAMPLE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE REASON WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775179 ↗
• MalfunctionFeb 18, 2025Migration; Migration

  MEDTRONIC RECEIVED A REPORT THAT AN ANTERIOR COMMUNICATING ARTERY COILING CASE WAS PLANNED WHERE THE 1ST COIL WAS PRIME 3D 2.5X6 WHICH WENT IN SMOOTHLY THROUGH AN OX ECHELON10 AND WAS DETACHED. NEXT A PRIME HELIX 2X4 WAS TAKEN WHICH SOMEHOW WAS NOT GOING THROUGH ECHELON HUB AND UPON OBSERVATION, IT WAS SEEN THE COIL TIP WAS BENT INSIDE THE WHITE INTRODUCER SHEATH. THE COIL WAS STUCK AT THE CATHETER HUB. THE IMPLANT COIL DID NOT PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE COIL IMPLANT WAS NOT COMING OUT OF THE INTRODUCER SHEATH. EVEN AFTER MULTIPLE ATTEMPTS THE COIL NEVER ENTERED THE CATHETER HUB. THERE WAS NO DAMAGE TO THE CATHETER OR COIL. AFTER MULTIPLE ATTEMPTS THE COIL WAS NOT GOING THROUGH THE HUB SO A 3RD COIL WAS TAKEN. A SAME SIZE OPTIMA 2X4 WAS THEN TAKEN AND AFTER DEPLOYMENT, IT WAS DETACHED. PRIME HELIX 1.5X4 WAS TAKEN AS THE 4TH COIL NOW AND AS SOON AS THE COIL WAS INTRODUCED INTO THE ECHELON HUB, THE COIL HAD STRETCHED. THE IMPLANT COIL WAS STRETCHED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. A 5TH COIL OF PRIME HELIX 1X2 W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399948 ↗
• MalfunctionJan 3, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO DETACHMENT ATTEMPTS. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. IT WAS REPORTED THAT AFTER THE COIL WAS REMOVED AND STANDARD HYDRATION WAS PERFORMED, THE COIL WAS FOUND TO BE ABNORMAL IN SHAPE UNDER THE DSA MACHINE WHEN PREPARING FOR EMBOLIZATION. THE COIL WAS THEN PUSHED OUT FOR OBSERVATION AND THE DETACHMENT POINT WAS FOUND TO BE BROKEN. CONSIDERING THE SURGICAL RISK, THE COIL WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21072967 ↗
• MalfunctionSep 12, 2024Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199723 ↗
• MalfunctionJul 9, 2024Break; Stretched; Detachment of Device or Device Component; Material Deformation; Packaging Problem; Break; Stretched; Detachment of Device or Device Component; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE IMPLANT COIL WAS STRETCHED AND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY COMMUNICATING SEGMENT WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN THE SURGEON TOOK THE SPRING COIL OUT OF THE PACKAGE, THEY FOUND THAT THE TAIL END HAD BEEN KINKED AND BROKEN AND STRETCHED. THEY PUSHED THE SPRING COIL INTO THE MICROCATHETER, BUT UNDER X-RAY, THEY COULD ONLY PUSH IT FORWARD AND COULD NOT WITHDRAW IT. THEREFORE, THEY JUDGED THAT THE COIL HAD BEEN DETACHED. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL 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 19701121 ↗
• MalfunctionJun 5, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE PUSHWIRE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467287 ↗
• MalfunctionMay 7, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SPRING COIL WAS BEING DELIVERED, IT GOT STUCK IN THE MIDDLE OF THE MICROCATHETER AND COULD NOT BE DELIVERED FURTHER. IT COULD BE DELIVERED AFTER REPLACING THE COIL. THERE WAS NO DAMAGE OBSERVED ON THE CATHETER. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED RIGHT OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.6 2.1MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE COIL DID COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264063 ↗
• MalfunctionDec 27, 2023Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT THE COIL WAS STRETCHED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WERE 3 COILS IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18406415 ↗
• MalfunctionOct 19, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  2MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM EMBOLIZATION, THE SURGEON USED AN AXIUM COIL THAT COULD NOT BE PUSHED OUT FROM THE PROTECTIVE SHEATH AFTER FULL SALINE PERFUSION, AND COULD NOT BE PUSHED INTO THE LESION POSITION, RESULTING IN THE INABILITY TO PERFORM THE OPERATION. AFTER REPLACING THE AXIUM COIL OF THE SAME MODEL, THE OPERATION WAS SUCCESSFULLY COMPLETED. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED RIGHT OPHTHALMIC SEGMENTAL ANEURYSM WITH A MAX DIAMETER OF 3.2MM AND A 2.8MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT DURING PREPARATION, 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 17965468 ↗
• MalfunctionMay 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 LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AFTER THE FIRST COIL WAS WAS SUCCESSFULLY DELIVERED, THE AXIUM COIL MODEL: APB-1-2-HX-ES, LOT: 222394274 WAS SELECTED. WHEN THE COIL WAS FULLY DEPLOYED, DETACHMENT WAS ATTEMPTED BUT THE COIL COULD NOT BE DETACHED. 3 ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID) WITHOUT SUCCESS. ANOTHER ID WAS TRIED ALSO WITHOUT SUCCESSFUL DETACHMENT. IT WAS NOTED THERE WAS NO ISSUE WITH THE ID'S. 3 ATTEMPTS WERE ALSO MADE TO DETACH THE COIL MANUALLY WITH THE HYPOTUBE WITHOUT SUCCESS. THE SURGEON THEN TRIED TO CLIP THE DETACH WIRE WITH TWEEZERS BUT IT STILL COULD NOT BE DETACHED. THE COIL WAS THEN WITHDRAWN AND REPLACED AND THE SURGERY WAS ABLE TO BE COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: EC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462742 ↗