AxiumTM APB-1.5-3-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536020955), received between Apr 4, 2019 and Jul 15, 2026 — classified as 1 injury, 10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25828396 ↗
• MalfunctionApr 2, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE PREMATURE DETACH AFTER NON-DETACHMENT WAS NOT DETERMINED. THERE WAS NO KINK/DAMAGE¿OBSERVED¿ON THE¿PUSHWIRE. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER TRYING TWICE AND BREAKING THE MANUAL DETACHMENT POINT, THE COIL COULD NOT BE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753622 ↗
• MalfunctionFeb 26, 2025Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED DUE TO THE DISTAL LOCATION AND BEING A SEPTAL COLLATERAL, THE VESSEL TORTUSOITY WOULD BE CLASSIFIED AS MODERATE. THEY HAVE ONLY 2 OF YOUR AXIUM COILS ON STOCK IN THE CATH LAB. DUE TO THE RUPTURE OF THE SEPTAL COLLATERAL THEY HAD TO OCCLUDE THE RUPTURED COLLATERAL ON BOTH ENDS FROM THE LEFT CORONARY SYSTEM AND THE RIGHT CORONARY ARTERY (RCA). THE FIRST COIL FROM THE LEFT CORONARY ARTERY (LCA)WAS ALREADY CORRECTLY PLACED AND THE PERFORATION OCCLUDED. THE SECOND ONE IN THE RCA WAS THE ONE THAT FAILED. AFTERWORDS THEY TRIED ALL THE RECOMMENDED BAIL OUT PROCEDURES FOR VESSEL PERFORATION INCLUDING BALLOON OCCLUSION, SUBCUTANEUS FAT INJECTION, PROTAMINE WITHOUT SUCCESS. FINALLY THEY FORMED A MAKESHIFT COIL FROM A WORKHORSE WIRE AND POSITIONED IT IN PLACE WITH A MICROCATHETER. THIS WAS SUCCESSFUL IN THE END. THE PATIENT WAS DOING WELL WITHOUT ANY RESIDUAL IMPAIRMENT. NO ATTEMPTS WERE MADE TO DETACH WITH THE INSTANT DETACHER. 3 MANUAL DETACHMENT ATTEMPTS WERE MADE. THE COIL WAS REMOVED FROM IT THE PACKAGE WITHOUT ANY ISSUES OR PROBLEMS VISIBLE. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470697 ↗
• MalfunctionFeb 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED RESISTANCE IN THE ECHELON CATHETER HUB. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITYWAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS GETTING STUCK AT HUB OF THE MICROCATHETER AND WAS NOT ENTERING THE CATHETER. THE FIRST COIL AXIUM 3D 3MMX6MM, WENT INSIDE VERY EASILY BUT BOTH THE HELIX COIL HAD ISSUE ENTERING THE HUB. IT WAS REPORTED THERE AS COIL RESISTANCE/STUCK AT THE CATHETER HUB. THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WAS NO CATHETER OR COIL DAMAGE OBSERVED. 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. ANCILLARY DEVICES INCLUDE A FUBUKI 6F 80CM SHEATH, NEURON 5F GUIDE CATHETER, ECHELON MICROCATHETER, TRAXCESS GUIDEWIRE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED REPORTED THE MICROCA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376619 ↗
• MalfunctionDec 8, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN TRIED USING THIS PRODUCT DURING THE USUAL EMBOLIZATION PROCEDURE. THE PRODUCT WAS TAKEN OUT OF THE PACKAGE, AND WHEN THE PREPARATIONS WERE ATTEMPTED, THE COIL'S DELIVERY WIRE PORTION WAS KINKED, SO IT WAS REPLACED WITH ANOTHER PRODUCT. AS SUCH, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT AFFECTED. FURTHERMORE, THERE WERE NO ABNORMALITIES IN THE APPEARANCE OF THE PACKAGE. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE WAS DISCOVERED DURING PREPARATION. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND AND NO ABNORMALITIES WHEN LOOKING OUTSIDE THAT PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290024 ↗
• MalfunctionMay 18, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. IT WAS REPORTED THAT THE COIL WAS NOT DETACHED USING THE INSTANT DETACHER, AND THE SECOND SEPARATION SYSTEM WAS REMOVED WITHOUT USING IT. THREE ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHER. MANUAL DETACHMENT WAS NOT ATTEMPTED, AND IT WAS UNKNOWN IF A SECOND INSTANT DETACHER WAS USED. 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 SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428491 ↗
• MalfunctionMar 17, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT TRAVEL ON THE DELIVERY WIRE BEFORE BEING INTRODUCED INTO THE PATIENT. WHEN PERFORMING THE TEST IN THE TUB WITH THE SERUM, IT DID NOT DETACH FROM THE DELIVERY WIRE. THERE WAS NO HARM TO THE PATIENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796083 ↗
• MalfunctionApr 20, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH VIA THE MANUAL METHOD. APB-1.5-3-HX-ES COULD NOT BE DETACHED, AFTER IT COMPLETELY ENTERED THE ANEURYSM. AN INSTANT DETACHER WAS NOT USED. 5 MANUAL DETACHMENT ATTEMPTS WERE MADE BUT ALL WERE UNSUCCESSFUL. IMAGES HAVE BEEN PROVIDED. THE PATIENT WAS TREATED WITH QC-1.5-2-HELIX AND APB-1.5-1-HX-ES AND THEY WERE USED SUCCESSFULLY. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR, CAVERNOUS SINUS ARTERY. THE MAX DIAMETER WAS 2.5 MM AND THE NECK WAS 2 MM. THE BLOOD FLOW AND VESSEL ANATOMY WERE BOOTH NORMAL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9976014 ↗
• MalfunctionSep 9, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED. IT WAS STATED THAT THIS WAS THE SIXTH COIL USED DURING THE PROCEDURE. THE PHYSICIAN ATTEMPTED 3 INSTANT DETACHMENT METHODS AS WELL AS MANUAL DETACHMENT BUT THE ISSUE PERSISTED. AS A RESULT THE COIL WAS REMOVED/REPLACED AND NOTED TO HAVE SEPARATED FROM THE RETAINER RING ONCE IT WAS WITHDRAWN FROM THE CATHETER HUB. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. THERE WERE NO RELATED PATIENT SYMPTOMS. THE ABNORMALITY WAS NOT LOCATED IN THE ELOQUENT REGION, THE PATIENT HAD A HIGH BLOOD FLOW AND MODERATE VESSEL TORTUOSITY. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. A SEPARATE INSTANT DETACHER WAS NOT ATTEMPTED. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. ANCILLARY DEVICES INCLUDE A COOK 6F SHUTTLE 80CM SHEATH, SL-10 MICROCATHETER, ASAHI CHIKAI GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8975954 ↗
• InjuryAug 14, 2019Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  MEDTRONIC RECEIVED REPORT THAT THE COIL WAS DELIVERED INTO THE ANEURYSM, WHEN THE COIL WAS PULLED OUT FOR REPOSITIONING, IT SEEMED THAT THE COIL HAD UNRAVELED (STRETCHED). ALTHOUGH IT WAS COLLECTED TOGETHER WITH THE SL-10 MICROCATHETER, THE COIL MIGRATED FROM THE ANEURYSM BY SEVERAL MILLIMETERS. WHEN THE DELIVERY PUSHER WAS CHECKED, IT WAS JUDGED THAT THE COIL WAS DETACHED, AND NOT UNRAVELED,AND IT WAS CONFIRMED BY CT THAT THE COIL HAD UNINTENTIONALLY DETACHED. A STENT WAS USED TO MITIGATE THE MIGRATED PORTION OF THE COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO DAMAGE TO THE PUSHWIRE AND NO RESISTANCE WAS FELT WHEN THE COIL WAS DELIVERED THROUGH THE CATHETER. THE COIL WAS ONLY REPOSITIONED ONCE. A CONTINUOUS FLUSH WAS USED DURING THE CASE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF AN UNRUPTURED LEFT INTERNAL CAROTID ARTERY ANEURYSM THAT WAS AMORPHOUS. THE MAX DIAMETER OF 5MM AND A NECK WIDTH OF 4MM. THE ANATOMY WAS SEVERE IN TORTUOSITY. THE BLOOD FLOW WAS NORMAL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8892432 ↗
• MalfunctionApr 4, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN COULD NOT DETACH THE COIL DURING THE PROCEDURE. IT WAS STATED THAT THE PHYSICIAN ATTEMPTED 2 TIMES TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN TRIED 2 TIMES WITH A SECOND INSTANT DETACHER TO TRY TO DETACH. THEY THEN ATTEMPTED 1 TIME TO DETACH MANUALLY VIA HYPTOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM WITH A MAX DIAMETER OF 5MM AND A NECK DIAMETER OF 3.5MM. THE ANEURYSM LOCATION WAS INDICATED AS A-COM ANEURYSM, 4.5MM*5MM. IT WAS NOTED THE VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8483843 ↗