AxiumTM APB-1-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00847536020917), received between Sep 6, 2018 and Mar 12, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IT WAS CLARIFIED THAT THE, "PROXIMAL END OF THE AXIUM COIL WIRE HAD ALREADY BEEN BROKEN" WAS IN REFERENCE TO SOME OTHER ISSUE. THE COIL DID NOT PREMATURELY SEPARATE FROM THE DELIVERY WIRE. PART OF THE PUSHWIRE DID NOT FRACTURE AND SEPARATE FROM THE REST. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSH WIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT IDENTIFIED. THE PROCEDURE COMPLETED BY REPLACING THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579351 ↗
• MalfunctionJan 22, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE COIL AXIUM COIL APB-1-2-HX-ES, LOT: 228392618 WAS DETACHED INTENTIONALLY. THE COIL WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210858 ↗
• MalfunctionOct 2, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO THE COIL NON-DETACHMENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20354289 ↗
• MalfunctionAug 22, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING AN "IA" PROCEDURE, THE PATIENT EXPERIENCED A VASCULAR DISSECTION, AND THE PHYSICIAN ASSISTED WITH A COIL EMBOLIZATION. HOWEVER, WHEN USING THE AXIUM COIL, THE DETACHER FAILED TO RELEASE THE COIL. EVEN AFTER SWITCHING TO A NEW DETACHER, THE COIL STILL COULD NOT BE RELEASED AFTER 1 ATTEMPT. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE PHYSICIAN THEN ATTEMPTED TO RELEASE THE COIL BY BREAKING THE BLACK PUSH WIRE AT THE DISTAL END AND PULLING ON THE MICROFILAMENTS IN THE MIDDLE 2 TIMES, BUT THIS METHOD ALSO FAILED. AFTER ANOTHER ATTEMPT TO BREAK THE BLACK PUSH WIRE, THE MICROFILAMENTS WERE NO LONGER VISIBLE, MAKING IT IMPOSSIBLE TO PULL THEM OUT. ULTIMATELY, THE UNRELEASED COIL WAS REMOVED FROM THE BODY, AND THE PROCEDURE WAS COMPLETED USING A COIL FROM ANOTHER MANUFACTURER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES. TH THE PATIENT WAS BEING TREATED FOR VESSEL DISSECTION. THE BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. ANCILLARY DEVICES INCLUDED ASAHI GUIDEWIRE, A NON-MEDTRONIC GUIDE CATHETER AND A NON-MEDTRONIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20040821 ↗
• MalfunctionAug 9, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE C6  WITH A MAX DIAMETER OF 4 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 THE AXIUM COIL COULD NOT BE DETACHED, SO REPLACED WITH ANOTHER MEDTRONIC COIL OF THE SAME MODEL AND THE OPERATION WAS CONTINUED. THE OPERATION WAS SUCCESSFUL. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948593 ↗
• MalfunctionMay 8, 2024Difficult or Delayed Positioning; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Difficult or Delayed Positioning; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE TECH AND THE DOCTOR FELT RESISTANCE WHEN PUSHING THE COIL UP THROUGH THE CATHETER SO THEY PULLED THE COIL OUT AND THE COIL WAS FRAYED. THEY DECIDED TO REPLACE THE COIL, TO AVOID CATHETER DAMAGE, AND COIL WAS REPLACED FOR ANOTHER ONE OF SAME SIZE AS PATIENT NEEDED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THE COIL WAS KINKED/DAMAGED. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE DISTAL SEGMENT WAS DAMAGED/STRETCHED. THE PHYSICIAN DID NOT TRY TO REPOSITION THE COIL DURING THE PROCEDURE. IT WAS NOTED THE COIL/SEPARATION/BREAK/PREMATURE DETACHMENT ALSO OCCURRED. THE COIL WAS REMOVED FROM THE PATIENT AND EXTRACTED FROM THE MICROCATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THERE WAS DIFFICULT PLACEMENT AND THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. THERE WERE NO ADDITIONAL STEPS/SURGICAL INTERVENTION REQUIRED TO REMOVE OR SECURE THE COIL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED AND THE ANEURYSM DID NOT RUPTURE. THE TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267912 ↗
• MalfunctionApr 23, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL GUIDEWIRE WOULD NOT ENTER THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR CLINOID SEGMENT RUPTURED ANEURYSM WITH A AMORPHOUS MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 5 MM, NECK DIAMETER 4 MM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (8 MM DIAMETER). THE VESSEL TORTUOSITY WAS MODERATE AND THE BLOOD FLOW WAS UNKNOWN. DURING THE SURGERY, THE GUIDE WIRE COULD NOT ENTER THE MICROCATHETER. THE SURGEON EVEN CHANGED TWO GUIDE WIRES BUT IT WOULD NOT ENTER. IT WAS BELIEVED THAT THERE WAS A PROBLEM WITH THE MICROCATHETER. WHEN THE COIL WAS APPLIED, IT WAS FOUND THAT THE GUIDE WIRE HAD BEEN KINKED WHEN THE COIL WAS OPENED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ANCILLARY DEVICES: SHEATH 8F CORDIS, GUIDE CATHETER NAVIEN, GUIDEWIRE SYNCHRO14 ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF RESISTANCE WAS A QUALITY PROBLEM WITH THE SPRING COIL MICROCATHETER. THE REASON FOR THE SUBSEQUENT COMPLAINT ABOUT THE SPRING COIL WAS THAT THE PUSH BA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167201 ↗
• MalfunctionJan 9, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS POOR DETACHMENT WITH THE AXIUM PRIME COIL. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE C3 SEGMENT OF THE LEFT INTERNAL CAROTID. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 1.4MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT NORMAL DETACHMENT WAS ATTEMPTED WITH THE INSTANT DETACHER TWICE, BUT THE COIL DID NOT DETACH. A SECOND INSTANT DETACHER WAS NOT USED. ONE MANUAL DETACHMENT ATTEMPT WAS MADE. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18478347 ↗
• MalfunctionDec 27, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT IN AN ANEURYSM COILING CASE, THE ID-1-5 USED TO DETACH COIL DIDN'T WORK, THEN MANUAL DETACHMENT WAS PERFORMED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE ANEURYSM WAS SMALL, SACCULAR, DOME-2.5, HEIGHT-6, AICA ANEURYSM. VESSEL TORTUOSITY WAS SEVERE. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. THERE WERE 7 ATTEMPTS MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THERE WAS 1 ATTEMPT MADE TO DETACH THE COIL USING THE MANUAL METHOD. THE COIL WAS A MEDTRONIC DEVICE; AXIUM PRIME, LOT::226556149,227008032 <(>&<)> 227052961. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399284 ↗
• MalfunctionDec 2, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL COULDN'T BE PUSHED OUT OF THE ECHELON10. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY 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. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH 8MM DIAMETER. (B)(6) 2022 E1 (REP, HCP, FOR): ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. (B)(6) 2022 E2 (REP, FOR): ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO FOREIGN BODY WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905242 ↗
• MalfunctionJun 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL STRETCHED AND SEPARATED/BROKE/PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3.21*4.67MM, AND THE NECK DIAMETER WAS 2.11MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MI NIMAL. IT WAS REPORTED THAT THE COIL WAS ADJUSTED INTRAOPERATIVELY AND AUTOMATICALLY STRETCHED. IT WAS SLOWLY WITHDRAWN TO THE INTERMEDIATE CATHETER WITH THE ECHELON 10 MICROCATHETER, AND THEN THE INFLATED BALLOON WAS PRESSED AGAINST THE SPRING COIL TO ASSIST ITS SLOW WITHDRAWAL FROM THE BODY. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS WERE MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS NOT ADMINISTERED. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632879 ↗
• MalfunctionNov 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME IMPLANT COIL WAS STRETCHED WHEN THE CUSTOMER WAS RETRIEVING THE COIL TO THE PROXIMAL PART THROUGH SL-10 MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY, AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE COIL 2-3 TIMES, BUT THEN THE COIL WAS REMOVED AND REPLACED BY ANOTHER MANUFACTURER'S PRODUCT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED, A-COM ANEURYSM WITH A MAX DIAMETER OF 3MM AND AN UNKNOWN NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE UNKNOWN. ANCILLARY DEVICES INCLUDE A SHUTTLE SHEATH, ENVOY DA 6F GUIDE CATHETER, AND SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9324197 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED REPORT THAT 2 PIPELINE FLEX WITH SHIELD (PED2) WERE USED TO RE-TREAT A NECK RECURRENCE (2 X 3 X 3MM) OF A RUPTURED AND COILED PCOMA-ANEURYSM (INITIALLY 8X5X4,5 MM).

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 8745065 ↗
• MalfunctionSep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS PRE-DETACHED IN THE MICROCATHETER. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. ANCILLARY DEVICES INCLUDE AN ENVOY DA GUIDE CATHETER AND AN SL-10 MICROCATHETER. THERE WERE NO RELATED PATIENT SYMPTOMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7852887 ↗