AxiumTM APB-2-8-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847536021020), received between Jul 29, 2019 and Apr 24, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME BARE HX COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR AN EMERGENT TAKEDOWN OF AN OROPHARYNGEAL BLEED AT THE LEVEL OF THE RIGHT SUPERIOR THYROID. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE COIL WAS THE 4TH AXIUM COIL TO BE INTRODUCED FOR EMBOLIZATION TO THE TAKEDOWN OF THE OROPHARYNGEAL ARTERY, WITH OTHER AXIUM COILS PRIOR DETACHING WITHOUT ISSUE. AFTER THREE FAILED ATTEMPTS TO DETACH THE COIL USING THE INSTANT DETACHER, SLIGHT RETRACTION OF THE MICROCATHETER WAS PERFORMED TO SEE IF THAT WOULD HELP DETACH, HOWEVER, THIS ATTEMPT WAS UNSUCCESSFUL. ONE MANUALLY DETACHMENT WAS THEN ATTEMPTED AT THE MANUAL BREAK POINT ON THE COIL PUSHER WIRE, BUT THIS ATTEMPT WAS ALSO UNSUCCESSFUL. WITHOUT ISSUE, THE COIL WAS FULLY REMOVED AND REPLACED WITH ANOTHER COIL OF THE SAME MODEL AND LOT, DETACHING WITHOUT ISSUE. THE OROPHARYNGEAL ARTERY EMBOLIZATION WAS SUCCESSFULLY EMBOLIZED WITHOUT PATIENT COMPLICATIONS WITH A TOTAL OF ELEVEN AXIUM COILS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ALL AXIUM COILS WERE PREP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24985604 ↗
• MalfunctionApr 23, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE/WAS STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE VIA FEMORAL ACCESS. PATIENT'S BLOOD FLOW WAS NORMAL; VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. WHEN ATTEMPTING TO DELIVER THE COIL INTO THE MICROCATHETER, IT BECAME STUCK IN THE SHEATH. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED STATING 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. ANCILLARY DEVICES: TERUMO SHEATH 5F, TERUMO VERT 5F GUIDE CATHETER, TERUMO PROGREAT MICROCATHETER, AND A TERUMO 035 GUIDEWIRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894313 ↗
• MalfunctionJan 15, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. THREE DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHER (ID). A SECOND ID WAS NOT USED. ONE MANUAL DETACHMENT ATTEMPT WAS ALSO UNSUCCESSFUL. THE COIL WAS REPLACED, AND THE PATIENT WAS SUCCESSFULLY TREATED. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS FISTULA EMBOLIZATION. THE LESION WAS NOT LOCATED IN THE FUNCTIONAL/ELOQUENT AREA. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161569 ↗
• MalfunctionSep 10, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED A DETACHMENT FAILURE (COULD NOT BE DETACHED). THE COIL WAS COLLECTED. IT WAS UNKNOWN IF THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). IT WAS UNKNOWN HOW MANY TIMES THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER. IT WAS UNKNOWN IF THE PHYSICIAN TRY TO DETACH WITH ANOTHER INSTANT DETACHER. IT WAS UNKNOWN IF THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPO TUBE. IT WAS UNKNOWN IF THE INSTANT DETACHER WOULD BE RETURNED FOR EVALUATION. IT WAS UNKNOWN IF THERE WERE ANY ISSUES WITH THE INSTANT DETACHER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES: MICROCATHETER UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20182393 ↗
• MalfunctionMay 9, 2024Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GRADE 1 NEUROVASCULAR ABNORMALITY THAT WAS LOCATED OUTSIDE THE ELOQUENT REGION. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE, THE COIL WAS DELIVERED TO THE DESIRED LOCATION BUT COULD NOT BE DETACHED. TWO ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE FIRST INSTANT DETACHER (ID) WITHOUT SUCCESS. ANOTHER ID WAS ALSO TRIED TWICE WITHOUT SUCCESSFUL DETACHMENT OF THE COIL. ONE ATTEMPT WAS ALSO MADE TO DETACH THE COIL MANUALLY WITHOUT SUCCESSFUL DETACHMENT. A SMALL FRACTURE WAS THEN OBSERVED IN THE PROXIMAL SEGMENT WITH WAS CONSIDERED TO BE CAUSING THE DETACHMENT FAILURE SO THE COIL WAS RETRIEVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. IT DID NOT PROLONG THE PATIENT'S HOSPITALIZATION AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279084 ↗
• MalfunctionOct 26, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING ONE ATTEMPT WAS MADE TO DETACH THE COIL USING THE MANUAL METHOD? PRIOR TO COIL NON-DETACHMENT NO ISSUES WERE ENCOUNTERED. THE DOCTOR CONFIRMED THAT THERE WERE NO DAMAGES TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18013784 ↗
• MalfunctionSep 22, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT 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 17799442 ↗
• MalfunctionMar 16, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN INSTANT DETACHER WAS NOT USED. ONE ATTEMPT WAS, MADE USING THE MANUAL METHOD. THE DOCTOR DID NOT KNOW WHAT CAUSED DAMAGE SINCE HE FRACTURED THE PUSHWIRE AS HE USED TO DO. THERE WAS NO ISSUE ENCOUNTERED BEFORE THE COIL NON-DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561163 ↗
• MalfunctionOct 27, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE SEEMED TO BE NO VISUAL ABNORMALITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15682009 ↗
• MalfunctionAug 31, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM SHEATH WAS DISCONNECTED WHEN THE HOOP WAS REMOVED. THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIN WAS BEING TREATED FOR VAD. BLOOD FLOW SPEED WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327686 ↗
• MalfunctionAug 11, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD RESISTANCE IN THE CATHETER AND DETACHED PREMATURELY. THE PATIENT HAD AN ANEURYSM AT THE END OF THE M1 SEGMENT OF THE BRAIN. USING STENT-ASSISTED SPRING COIL EMBOLIZATION. FILLING WITH AXIUM APB-2-8-HX-ES, AND THERE WAS A LOT OF RESISTANCE DURING THE FILLING PROCESS. MOREOVER, IT WAS FOUND THAT THE SPRING COIL WAS AUTOMATICALLY DETACHED FROM THE MICRO-CATHETER, THIS SPRING COIL HAD QUALITY PROBLEM AND WOULD NOT BE CHARGED. THE COIL WAS REMOVED FROM THE PATIENT BY WITHDRAWING THE MICROCATHETER. NO SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED. THE PHYSICIAN DID NOT REPOSITION THE COIL, ATTEMPT TO DETACH THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURYSM IN THE LEFT SIDE OF THE BRAIN. THE MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215112 ↗
• MalfunctionNov 9, 2021Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE SHEATH WAS STUCK IN THE PUSHWIRE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM AT THE BA (BASILAR ARTERY) TIP WITH A MAX DIAMETER OF 9MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT WHILE INSERTING THE PRODUCT INTO SL10, THE INTRODUCER SHEATH WAS STUCK IN THE PROXIMAL PORTION OF THE DELIVERY PUSHWIRE WHEN THE INTRODUCER SHEATH WAS REMOVED, AND THE COIL WAS DETACHED IN THE MICROCATHETER. THE COIL REMAINING IN THE MICROCATHETER WAS PUSHED FORWARD WITH THE DELIVERY PUSHWIRE AND IMPLANTED IN THE ANEURYSM. THE COIL WAS PLACED IN THE EXPECTED POSITION. NO ADDITIONAL SURGICAL OR MEDICAL PROCEDURES WERE PERFORMED. THE DELIVERY PUSHER WAS NOT DEFORMED OR DAMAGED. THERE WAS NO RESISTANCE DURING DELIVERY. THE COIL WAS NOT RELOCATED AND THEY DID NOT TRY TO DETACH THE COIL. THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODY. THE FLUSH WAS PERFORMED DURING THE PROCEDURE WITHOUT INTERRUPTION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783971 ↗
• MalfunctionJul 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT SEVERAL DETACHMENT ATTEMPTS WERE MADE BOTH MANUALLY AND WITH THE INSTANT DETACHER. THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12192813 ↗
• MalfunctionMay 27, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THREE ATTEMPTS WERE MADE TO DETACH THE COIL WITH THE INSTANT DETACHER AND ONE ATTEMPT WAS MADE AT MANUAL DETACHMENT. THERE WERE NO ISSUES ENCOUNTERED DURING THE PROCEDURE PRIOR TO THE NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED. TWENTY OTHER COILS WERE SUCCESSFULLY DETACHED WITH THE SAME INSTANT DETACHER SO IT WAS NOT CONSIDERED PART OF THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892838 ↗
• MalfunctionOct 23, 2020Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE AXIUM COIL HAD A DEFECT WITH RELEASE/PROGRESSION DURING THE PROCEDURE. THE REPORT STATED NO ADDITIONAL INFORMATION COULD BE PROVIDED, AND FOLLOW-UP WAS NOT POSSIBLE. THERE WAS NO PATIENT INJURY REPORTED WITH THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10729021 ↗
• MalfunctionJul 17, 2020Stretched; Stretched

  IT WAS REPORTED THAT THE COIL BECAME STRETCHED WHILE PULLING IT OUT OF THE ANEURYSM. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN REPOSITIONED THE COIL 2-3 TIMES DURING THE PROCEDURE. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 6.2 MM AND A NECK DIAMETER OF 3.6 MM. 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. THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE CATHETER PASSED THROUGH THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO RESISTANCE FELT IN THE CATHETER DURING DELIVERY OR RETRIEVAL OF THE COIL. THE REP STATED THE DEVICE WAS RETURNED BUT TRACKING INFORMATION WAS UNKNOWN. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10287568 ↗
• MalfunctionMar 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE COIL GOT STUCK INSIDE THE INTRODUCER SHEATH. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN ANEURYSM LOCATED AT THE POSTERIOR COMMUNICATING ARTERY. IT WAS NOTED THERE WAS NO VESSEL TORTUOSITY. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGED OBSERVED ON THE COIL. THE INTRODUCER SHEATH HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE AS IT WAS HYDRATED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9900473 ↗
• MalfunctionJul 29, 2019Activation Problem; Activation Problem

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH AND UPON REMOVED OF THE COIL IT UNINTENTIONALLY DETACHED. A NEW COIL WAS USED TO TREAT THE PATIENT. NO PATIENT INJURY OCCURRED. TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER. A SECOND DETACHER AND MANUAL DETACHMENT WERE NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8836274 ↗