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

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00847536020900), received between Mar 6, 2020 and Apr 8, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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.

• MalfunctionApr 8, 2026Therapy Delivered to Incorrect Body Area; Retraction Problem; Detachment of Device or Device Component; Migration; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED AND REMAINS IN THE PATIENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PATIENT PRESENTED AS A SUBACUTE RUPTURE TO THE ANTERIOR CIRCULATION AND UPON ANGIOGRAPHY WAS DETERMINED TO BE A RUPTURED BLISTER ANEURYSM OF A FENESTRATED VESSEL CONNECTED BETWEEN THE TWO ANTERIOR CEREBRAL VESSELS AT THE MID A2 JUNCTION. ACCESSING THE LEFT INTERNAL CAROTID ARTERY (ICA) VIA A 6FR. ZEBRA GUIDE, AN EXCELSIOR SL-10 MICROCATHETER WAS GUIDED TO THE A2 FENESTRATION VIA AN ARISTOTLE 14 SOFT GUIDE WIRE TO THE SITE OF THE BLISTER ANEURYSM. THE PHYSICIAN ATTEMPTED TO INSERT A STRYKER TARGET NANO COIL 1X2 (REF# (B)(4), LOT# 25675817) INTO THE BLISTER ANEURYSM WITHOUT SUCCESS AND WAS REMOVED WITHOUT ISSUE. THE PHYSICIAN THEN ATTEMPTED TO TREAT THE BLISTER ANEURYSM WITH AN AXIUM PRIME EXTRA SOFT COIL 1 X 1, WITH THE INITIAL COIL LOOP ACCESSING THE BLISTER ANEURYSM, BUT THE PHYSICIAN WORRIED IT WOULD NOT STAY IN PLACE, THUS BEGAN TO RET RACT THE LOOP BACK INTO THE SL-10 MICROCATHETER. DURING RETRACTION OF THE AXIUM PRIME EXTRA SOFT COIL 1 X 1, THE COIL PREMATURELY DETACHED AND

  Patient problems: Foreign Body In Patient; Muscle Weakness/Atrophy

  MAUDE report 24817005 ↗
• MalfunctionFeb 27, 2026Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE REPORTED ISSUE WAS A DEVICE ISSUE INVOLVING PREMATURE COIL DETACHMENT. RESISTANCE WAS FELT ON THE FRONT SIDE DURING COIL INSERTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, BUT THE COIL ITSELF WAS DETACHED AND REMAINS IMPLANTED. NO KINK OR DAMAGE TO THE CATHETER WAS OBSERVED AFTER REMOVAL, AND THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THERE WERE NO PARTICULAR ISSUES THAT RESULTED IN THE DAMAGE FOUND. DUE TO PREMATURE DETACHMENT, NORMAL DETACHMENT METHODS WERE NOT USED. NO KINK OR DAMAGE WAS OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470830 ↗
• MalfunctionFeb 25, 2026Stretched; Use of Device Problem; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT 4 COILS HAD ALREADY BEEN DETACHED WITH THE AXIUM INSTANT DETACHER. WHEN THE 5TH COIL (AXIUM PRIME BARE COIL) WAS TO BE DETACHED, IT WAS CONFIRMED THAT THE RELEASE WIRE LENGTH HAD EXTENDED, AND AN ATTEMPT WAS MADE TO PULL THE WIRE, BUT DETACHMENT WAS NOT ACHIEVED AND THE COIL WAS PULLED BACK. THE DETACHER KNOB WAS PULLED 4~5 TIMES, BUT DETACHMENT STILL DID NOT OCCUR. THE DETACHER WAS REPLACED, BUT DETACHMENT WAS STILL UNSUCCESSFUL. WHEN THE PORTION OF THE COIL THAT HAD COME OUT OF THE ANEURYSM WAS PUSHED BACK INTO THE ANEURYSM, DETACHMENT WAS FINALLY ACHIEVED. THE DISTAL END OF THE RELEASE WIRE BECAME CAUGHT IN THE DETACHER AND COULD NOT BE REMOVED; ONLY WITH FORCE WAS THE WIRE FINALLY PULLED OUT FROM THE DETACHER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION, HOWEVER, IT WAS REPORTED THE PATIENT'S LESION DETAILS, BLOOD FLOW, AND VESSEL TORTUOSITY WERE UNKNOWN. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER FIVE TIMES. THE PHYSICIAN ATTEMPTED TO "WITHDR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443501 ↗
• MalfunctionAug 22, 2024Break; Stretched; Separation Failure; Detachment of Device or Device Component; Break; Stretched; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT A COIL HAD SEPARATION/BREAK/PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT POSTERIOR COMMUNICATING SEGMENT ANE URYSM OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.7MM AND A 2.4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE ANEURYSM EMBOLIZATION PROCESS, THE LAST COIL FILLING COMPLETED, AND WHEN IT WAS DETACHED, IT WAS FOUND THAT THE SPRING COIL COULD NOT BE DETACHED. AFTER REMOVAL, IT WAS FOUND THAT THE SPRING COIL WAS STRETCHED. THE COIL WAS REMOVED FROM THE MICROCATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 1 TIME AND WITH THE MANUAL METHOD 1 TIME. THERE WAS 1 INSTANT DETACHER USED. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026397 ↗
• InjuryFeb 23, 2024Separation Failure; Unintended Movement; Separation Failure; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL DID NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A PREVIOUSLY RUPTURED  AND CLIPPED, RESIDUAL NECK ANEURYSM IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) WITH A MAX DIAMETER OF 1.8 MM AND A 1.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING ANEURYSM TREATMENT OF A RESIDUAL NECK REMNANT AN SL-10 WAS PLACED INTO THE ANEURYSM AND A 1X1 HELIX ES AXIUM WAS PLACED. THE COIL LOOKED SECURE AND FILLED THE ANEURYSM WELL. THE COIL WAS DETACHED BUT UPON SLOW REMOVAL OF THE WIRE THE COIL EVENTUALLY POPPED OUT OF THE ANEURYSM. THE WIRE AND CATHETER WERE RETRACTED AND THE COIL CAME OUT AS WELL. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER ONE TIME. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE NOT PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU), SPECIFICALLY THERE WAS NO DRIP LINE ATTACHED TO THE MICROCATHETER

  Patient problems: Vasoconstriction

  MAUDE report 18770313 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PROCEDURE BEING PERFORMED WAS COIL ASSISTANT STENT. VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE CAUSE OF THE COIL KINK/DAMAGE WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. (B)(6) DETACHMENT ATTEMPTS WERE MADE WITH THE COIL. (B)(6) TOTAL COILS IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL. THE PATIENT WAS BEING TREATED FOR HEMORRHAGE, NOT ISCHEMIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257218 ↗
• InjuryMay 22, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL SEPARATED AND CAUSED ARTERY OCCLUSION. DURING THE TRANS ARTERIAL EMBOLIZATION (TAE) PROCEDURE, WHEN THE LAST WAS INSERTED, THE DOCTOR WANTED TO ADJUST THE POSITION, AND HE FOUND THAT THE FRONT OF THE COIL DID NOT MOVE WITH THE MAKER. WHEN HE WITHDREW THE MICROCATHETER, THE DISTAL COIL CAME OUT. THE DOCTOR INFERRED THAT THE COIL WAS PARTIALLY DISSOCIATED. FINALLY, HE PUSHED THE DISTAL COIL AGAIN AND DISSOCIATED THE DISTAL COIL COMPLETELY. HOWEVER, HE TOOK THE ANGIO AND FOUND THE PROXIMAL COIL HAD BLOCKED THE PART OF ACA, CAUSING THE FLOW OF THE ACA WAS BLOCKED. BECAUSE OF THE DISSOCIATION OF COIL, THE DOCTOR COULD NOT ADJUST THE POSITION, SO HE PLACED A STENT TO HELP THE BLOOD FLOW UNBLOCK. THE COIL WAS NOT PLACED AT THE INTENDED LOCATION. THE PUSHWIRE WAS NOT BENT OR BROKEN. HERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A S ACCULARM RUP

  Patient problems: Obstruction/Occlusion

  MAUDE report 16975216 ↗
• MalfunctionApr 17, 2023Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16752630 ↗
• InjuryNov 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. COIL DISLODGEMENT WAS OBSERVED IN THE IC IN PRIME HELIX1-1 WHEN IT WAS BEING EMBOLIZED OVER THE LVIS BLUE, SO A SPONTANEOUS DETACHMENT OCCURRED WHEN AN ATTEMPT WAS MADE TO REMOVE IT. ABOUT 0.5 CM OF THE PROXIMAL EDGE OF THE COIL WAS IN THE HEADWAY DUO, BUT AN ATTEMPT WAS MADE TO REMOVE IT GENTLY WHILE IT WAS STILL ATTACHED TO THE MICROCATHETER ON 4.2 F FUBUKI. UNFORTUNATELY, JUST BEFORE THE HEADWAY DUO ENTERED THE FUBUKI, THE COIL MASS REMAINED AT THE TIP OF THE FUBUKI. WHEN THE FUBUKI WAS REMOVED WHILE CARRYING OUT A MANUAL FUNCTION IMMEDIATELY, THE COIL WAS SUCCESSFULLY REMOVED. CERTAINLY, AGAIN, THE HEADWAY DUO WAS ENGAGED AND THE AXIUM PRIME HELIX 1X1 WAS SOMEHOW, THE PLACEMENT WAS WITHDRAWN. THE COIL WAS PLACED IN THE INTENDED POSITION. SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED TO REMOVE DISLODGED COIL. THERE WAS NO RESISTANCE DURING DELIVERY. THE COIL WAS REPOSITIONED WITH 1 CYCLE OF REPOSITIONING. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL.  THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT.  PATIENT BLOOD FLOW SPEED WAS NORMAL. NO OTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.  ANCILLARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712373 ↗
• MalfunctionOct 29, 2022Material Too Rigid or Stiff; Detachment of Device or Device Component; Material Too Rigid or Stiff; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697079 ↗
• MalfunctionApr 30, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL WAS STRETCHED IN THE MICROCATHETER, AND UNABLE TO BE REMOVED, SO THE ECHELON WAS CUT IN AN ATTEMPT TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11754469 ↗
• MalfunctionApr 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DETACHED PREMATURELY, IN THE CATHETER. AS A RESULT THE MICROCATHETER WAS RETRIEVED WITH THE COIL INSIDE. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WAS NO DAMAGE SEEN TO THE PUSHER, THE DELIVERY PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODY, AND NO DETACHMENT ATTEMPTS WERE MADE. ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681312 ↗
• MalfunctionMar 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR CARDIAC FISTULA EMBOLIZATION. THE PATIENTS BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT WHEN REMOVING THE SPRING FROM THE PROTECTION SHEATH, THE SPRING WAS ALREADY DETACHED, MAKING IT IMPOSSIBLE TO USE. THE SPRING COIL WAS REMOVED FROM THE PATIENT AND NOT IMPLANTED. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE HAD BEEN NO FRICTION OR DIFFICULTY, NO DETACHMENT ATTEMPTS, NO REPOSITIONING, NO ROTATION OF THE DELIVERY WIRE, AND NO PROBLEMS WITH THE INSTANT DETACHER. A CONTINUOUS FLUSH WAS NOT USED. 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 11405158 ↗
• MalfunctionMar 6, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT THREE ATTEMPTS WAS MADE TO DETACH THE COIL USING THE INSTANT DETACHER, BUT IT FAILED. THE MANUAL DETACHMENT METHOD WAS THEN USED ABOUT THREE TIMES, BUT THE COIL STILL FAILED TO DETACH. 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 A 6FR SHEATH, ROADMASTER GUIDECATHETER, PHENOM MICROCATHETER, TRAXCESS GUIDEWIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9802783 ↗