AxiumTM APB-2-3-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536020993), received between Dec 14, 2018 and Apr 2, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (4 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.

• MalfunctionApr 2, 2025Contamination /Decontamination Problem; Material Deformation; Physical Resistance/Sticking; Contamination /Decontamination Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE/WAS STUCK IN THE CATHETER DURING DELIVERY. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS CAREFULLY INTRODUCED IN THE MICROCATHETER BUT AFTER INTRODUCTION, THE COIL COULD NOT PASS. IT WAS NOTED A "WIDER JACKET" WAS TRIED BUT ALSO DID NOT WORK. THE COIL WAS THEN REPLACED WITH ANOTHER OF THE SAME SIZE WHICH WAS USED SUCCESSFULLY WITHOUT ISSUE. THE CAUSE WAS NOT DETERMINED BUT IT WAS THOUGHT THAT THE COIL MAY HAVE BEEN DAMAGED OR CONTAMINATED WITH FIBERS CAUSING THE RESISTANCE SINCE THE REPLACEMENT OF THE SAME MODEL WAS USED WITH NO PROBLEM; HOWEVER THIS WAS NOT CONFIRMED. PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753559 ↗
• MalfunctionJul 31, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL STRETCHED DURING USE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, RUPTURED, RIGHT IC ANEURYSM WITH A MAX DIAMETER OF 4.3MM AND A 3.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL WAS CHOSEN AS THE FINAL CLOSING COIL. NORMAL HYDRATION WAS PERFORMED, AND PUSHING THE COIL THROUGH THE MICROCATHETER. HOWEVER, IT WAS PUSHED OUT ABOUT ONE THIRD OF THE COIL, AND THE HEALTHCARE PROVIDER (HCP) FELT THE RESISTANCE INTO THE ANEURYSM WAS INCREASED. THE COIL WAS WITHDRAWN AND IT WAS FOUND THE LENGTH WAS INCORRECT AS THE COIL WAS UNWINDING/STRETCHED. IT WAS CLARIFIED THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY, AND A CONTINUOUS FLUSH WAS ADMINISTERED. REPOSITIONING OF THE COIL DID NOT OCCUR. ANOTHER PRODUCT OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. 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. ANCILLARY DEVICES INCLUDE AN ENVOY GUIDE CATHETER, ECHELON 10 MICROCATHETER, AND SYNCHRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430592 ↗
• MalfunctionMay 23, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL WAS STUCK IN THE PROXIMAL SECTION OF THE CATHETER. THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE CATHETER WAS NOT DAMAGED. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED NO PATIENT WAS INVOLVED WITH THE EVENT.  ANCILLARY DEVICES: ENBOY 7F GUIDE CATHETER, HEADWAY 17 MICROCATHETER, SYNCHRO14 GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987719 ↗
• MalfunctionMar 29, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE STRETCHED.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM 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 MINIMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  IT WAS REPORTED THAT FOR ANEURYSM EMBOLIZATION, AFTER THE COIL WAS FORMED A HOOP, USED APB-2-3-HX-ES COIL TO FILL, THE COIL WAS STRETCHED, REPLACED WITH ANOTHER APB-1.5-4-3D-ES COIL, AND THE TAIL END WAS STRETCHED, REPLACED WITH OTHER SPECIFICATIONS OF THE COIL TO COMPLETE THE OPERATION SUCCESSFULLY. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NEW INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16634989 ↗
• MalfunctionNov 1, 2022Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SHAFT PORTION THAT AN AXIUM COIL WAS BROKEN WHEN IT WAS OPENED. IT WAS DAMAGED IN THE PUSHER CENTER PART. THE COIL WAS NOT REPOSITIONED. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. IT WAS REPORTED THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712436 ↗
• MalfunctionSep 8, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 6.3MM, AND THE NECK DIAMETER WAS 3.1MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT AFTER FILLING, THE COIL WAS DETACHED AND THE DETACHMENT WIRE WAS PULLED OUT OF THE PUSH ROD. THERE WAS NO OBVIOUS RESISTANCE WHEN THE PUSH ROD WAS WITHDRAWN. WHEN IT WAS WITHDRAWN OUTSIDE OF THE BODY, IT WAS FOUND THAT THE DETACHMENT AREA OF THE SPRING COIL WAS NOT DETACHED AND PART OF THE COIL BODY WAS STILL CONNECTED TO THE PUSH ROD BY THE DETACHMENT AREA. BUT THE COIL BODY WAS INCOMPLETE, THE LENGTH WAS LESS THAN 3CM, AND THE BROKEN END OF THE COIL BODY HAD OBVIOUS WIRE DRAWING. THE FLUOROSCOPY AND ANGIOGRAPHY SHOWED NO ABNORMAL BLOOD VESSELS AND DETACHMENT OF THE INTRATUMOR COIL BODY. THEREFORE, THE SURGERY WAS COMPLETED AND THE PATIENT HAD NO ADVERSE REACTIONS. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION, AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE HAD BEEN NO FRICTION/DIFFICULTY DURING DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15385884 ↗
• MalfunctionAug 10, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT 2 AXIUM COIL HAD RESISTANCE IN THE CATHETER AND DETACHED PREMATURELY. THE POSITION OF THE QC-2-3-HELIX DETACHABLE COIL WAS NOT IDEAL WHEN THE MICROCATHETER WAS PUSHED INTO THE ANEURYSM. WHEN READJUSTING, IT WAS FOUND THAT THE SPRING COIL COULD NOT BE PUSHED OUT. THE MICROCATHETER WAS PUSHED OUT FOR IN VITRO INSPECTION, FOUND THAT THE COIL HAD BEEN DETACHED ON ITS OWN IN ADVANCE. AFTER THE MICROCATHETER WAS IN PLACE AGAIN, SELECTED APB-2-3-HX-ES FOR FILLING. THE COIL WAS PUSHED INTO THE ANEURYSM. WHEN ADJUSTING THE FILLING, IT WAS FOUND THAT THE COIL COULD NOT BE PUSHED OUT AGAIN. BUT THE PUSH ROD COULD BE WITHDREW. WHEN WITHDRAWING, IT WAS FOUND THAT THE SPRING COIL HAD ALSO DETACHED IN ADVANCE. AFTER THE MICROCATHETER WAS IN PLACE AGAIN, CHOSE APB-1.5-3-HX-ES FOR EMBOLIZATION. THE SURGERY ENDED SUCCESSFULLY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE ANTERIOR  COMMUNICATING ARTERY ANEURYSM. THE MAX DIAMETER WAS 2.3MM AND THE NECK DIAMETER WAS 1.6MM. NO PATIENT INJURY OR SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201761 ↗
• MalfunctionJun 28, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A FRAME WAS CREATED USING TARGET360ULTRA, AND WHEN THE PRODUCT WAS INSERTED, DETACHMENT WAS NOT POSSIBLE. EVEN WHEN THE WIRE WAS FOLDED DETACHMENT WAS NOT POSSIBLE, SO THE PRODUCT WAS COLLECTED. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER SEVERAL TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE ONE TIME. A SECOND AXIUM COIL WAS INSERTED AND AN ATTEMPT WAS MADE TO PLACE THE PRODUCT, HOWEVER, THE COIL WAS STUCK AT THE CATHETER HUB. THE COIL WAS COLLECTED AND THE PROCEDURE WAS FINISHED. THE COIL SMOOTHLY EXTENDED FROM THE INTRODUCER SHEATH. IT WAS UNKNOWN IF THE CATHETER OR COIL WERE DAMAGED DURING THE ATTEMPT. THERE WAS NO HEALTH DAMAGE PRESENT. THE PATIENT'S BLOOD FLOW SPEED WAS UNKNOWN AND THE DEGREE OF VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE: PHENOM17 MICROCATHETER AND CHIKAI14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843883 ↗
• MalfunctionMar 8, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS MALFORMATION/FISTULA. THE LESION WAS LOCATED IN THE FUNCTIONAL AREA OF THE BRAIN (ELOQUENT AREA). THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THREE DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND NO MANUAL ATTEMPTS HAD BEEN MADE. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13689978 ↗
• MalfunctionJul 2, 2019Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Unintended Movement; Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT, THE MICROCATHETER KICKED BACK. AS A RESULT THE PHYSICIAN TRIED TO REPOSITION BUT THE COILS BECAME STRETCHED AND DETACHED SUDDENLY. THE COIL WAS REMOVED USING 2 STENT RETRIEVERS. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR RIGHT MCA ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A NECK DIAMETER OF 5MM. IT WAS NOTED THAT THE BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL, NOR DID THEY ROTATE THE DELIVERY PUSHER DURING PROCEDURE. A CONTINUOUS FLUSH WAS USED. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A NEURONMAX SHEATH, SYNCHRO GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8754802 ↗
• MalfunctionMar 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN COULD NOT DETACH THE COIL IMPLANT EVEN WHEN THE BACK UP DETACHMENT METHOD WAS USED. IT WAS STATED THAT THE PHYSICIAN ATTEMPTED OVER 3 TIMES TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN TRIED OVER 3 TIMES WITH A SECOND INSTANT DETACHER TO TRY TO DETACH. THEY THEN ATTEMPTED OVER 3 TIMES TO DETACH MANUALLY VIA HYPTOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM. IT WAS NOTED THE VESSEL TORTUOSITY AND PATIENT'S BLOOD FLOW WAS NORMAL. 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 8460674 ↗
• MalfunctionDec 14, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE COIL WAS UNABLE TO BE DETACHED WITH THE INSTANT DETACHER (3 ATTEMPTS) OR VIA MANUAL DETACHMENT (2 ATTEMPTS). THE INSTANT DETACHER WAS DISCARDED AT THE SITE. THERE WAS NO ISSUE WITH THE DETACHER. THERE WAS NO VISIBLE DAMAGE TO THE COIL OR THE CATHETER PRIOR TO USE. THE ANATOMY AND THE BLOOD FLOW WERE REPORTED TO HAVE BEEN NORMAL. NO INJURY WAS REPORTED TO HAVE OCCURRED. THE PROCEDURE WAS COMPLETED USING NEW COILS. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8165738 ↗