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AxiumTM APB-5-15-3D-SSRecalls & reported problems

Micro Therapeutics, Inc. · APB-5-15-3D-SS PRIME BARE AXIUM COIL · Class 2 · Implant

All models of AxiumTM (139)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
17
Deaths reported
1
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00847536008212), received between Nov 20, 2018 and Feb 18, 2026 — classified as 1 death, 4 injuries, 12 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component9
  • Physical Resistance/Sticking7
  • Separation Failure5
  • Stretched3
  • Migration1
  • Unintended Movement1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • No Known Impact Or Consequence To Patient4
  • Intracranial Hemorrhage1
  • Obstruction/Occlusion1

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 18, 2026Separation Failure

    MEDTRONIC RECEIVED A REPORT THAT A MICROCATHETER WAS ACCESSED INTO THE ANEURYSM, AND AFTER THE CORRESPONDING AXIUM COIL WAS DEPLOYED, DETACHMENT WAS ATTEMPTED BUT THE COIL COULD NOT BE DETACHED. EMERGENCY DETACHMENT WAS ALSO UNSUCCESSFUL, SO THE COIL WAS REMOVED AND DISCARDED ALONG WITH THE DETACHER WITHIN THE HOSPITAL. AXIUM COIL DETACHMENT FAILURE OCCURRED. EMERGENCY DETACHMENT WAS ALSO ATTEMPTED BUT WAS NOT POSSIBLE. THERE WAS POOR DISLODGEMENT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE INSTANT DETACHER 5 TIMES. THE PHYSICIAN DID NOT ATTEMPT TO WITHDRAW USING ANOTHER INSTANT DETACHER. THERE WAS 1 ATTEMPT (EMERGENCY WITHDRAWAL) MADE TO REMOVE THE DEVICE MANUALLY VIA THE HYPOTUBE. THE PRODUCT WAS NOT USED IN AN INFECTED PATIENT. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24377014 ↗
  • MalfunctionJul 11, 2025Use of Device Problem; Separation Failure; Use of Device Problem; Separation Failure

    MEDTRONIC RECEIVED A REPORT THAT DURING COIL EMBOLIZATION OF A CEREBRAL ANEURYSM, THE AXIUM COIL WAS USED AS THE FIRST COIL FOR EMBOLIZATION. AFTER SEVERAL REWINDING ATTEMPTS, DETACHMENT WAS ATTEMPTED BUT COULD NOT BE ACHIEVED. THE BEHAVIOR SUGGESTED UNRAVELING, AND THE PHYSICIAN DETERMINED IT TO BE A MALFUNCTION AND PERFORMED RETRIEVAL. THE COIL WAS SUCCESSFULLY RETRIEVED, BUT UPON EXAMINATION OF THE RETRIEVED COIL, A BLUE WIRE WAS VISIBLE. SUBSEQUENTLY, EMBOLIZATION WAS CONTINUED USING A DIFFERENT LOT OF COILS FROM THE SAME COMPANY. THE PHYSICIAN ATTEMPT TO DETACH THE COIL USING THE INSTANT DETACHER (ID) TWICE, IT WAS UNKNOWN IF THE ID HAD ANY DEFECTS. THEY DID NOT ATTEMPT TO WITHDRAW USING ANOTHER INSTANT DETACHER AND IT WAS UNKNOWN IF THERE WAS AN ATTEMPT MADE TO REMOVE THE DEVICE MANUALLY VIA THE HYPOTUBE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22479044 ↗
  • MalfunctionNov 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

    MEDTRONIC RECEIVED A REPORT THAT WHEN THE AXIUM COIL WAS INSERTED AND THE SHEATH WAS REMOVED, IT GOT CAUGHT ON THE WIRE, THE SHEATH COULD NOT BE REMOVED FROM THE WIRE, SO IT WAS COLLECTED. INITIALLY, 5 MM×10 MM WAS USED BUT THE SHEATH COULD NOT BE REMOVED; THE SIZE WAS CHANGED TO 5 MM×15 MM, BUT AGAIN, THE SHEATH COULD NOT BE REMOVED, SO IT WAS COLLECTED IN THE SAME MANNER. WHEN TRYING TO REMOVE THE SHEATH, PULLED HARD ENOUGH THAT IT STRETCHED, BUT IT WOULD NOT COME OUT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE IS NO PATIENT INVOLVED IN THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20669495 ↗
  • MalfunctionOct 24, 2024Separation Failure; Separation Failure

    ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE COMPLETED BY EMBOLIZATION USING A COIL FROM ANOTHER COMPANY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20528223 ↗
  • MalfunctionMay 2, 2023Stretched; Separation Failure; Stretched; Separation Failure

    MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STRETCHED AND COULD NOT BE DETACHED.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE COIL WAS FULLY DEPLOYED AND READY TO BE DETACHED. AFTER ATTEMPTING 3 TIMES WITH THE MEDTRONIC DETACHER, THE COIL WOULD NOT RELEASE. THE DOCTOR THEN TRIED USING THE BREAK POINT TO MANUALLY RELEASE THE COIL, AND IT DID NOT RELEASE EITHER. UPON INSPECTION AFTER PULLING THE COIL COMPLETELY OUT OF THE PATIENT, IT APPEARS TO HAVE SHEARED/STRETCHED AT THE DETACHMENT POINT. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATION WAS ON THE IMPLANT COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A TERUMO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16853936 ↗
  • MalfunctionApr 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

    MEDTRONIC RECEIVED A REPORT REGARDING AXIUM COIL RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 7.5 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS LOW AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER TAKING OUT THE DEVICE ACCORDING TO THE REGULAR PROCEDURE AND HYDRATING IT, THE SPRING COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SHEATH, AND ANOTHER MODEL PRODUCT WAS REPLACED, AND THE OPERATION WENT SMOOTHLY. 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. ADDITIONAL INFORMATION WAS RECEIVED THAT RESISTANCE WAS LOCATED IN THE PROTECTIVE SHEATH. THE COIL WAS STRETCHED AFTER REMOVAL. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16708983 ↗
  • DeathDec 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

    MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY. THE SPRING COIL WAS DETACHED IN ADVANCE IN THE MICROCATHETER. THE COIL WAS REMOVED FROM THE PATIENT USING THE STENT TO TAKE IT OUT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A SACCULAR ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 5MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. THE PATIENT IS DECEASED AND THE CAUSE OF DEATH WAS REPORTED AS INTRACEREBRAL HEMORRHAGE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DIED AT THE TREATING HOSPITAL IN (B)(6) 2022, THE PRECISE DATE WAS NOT PROVIDED. PER THE SITE, THE PATIENT'S DEATH WAS NOT RELATED TO THE AXIUM COIL. NO OTHER INFORMATION WAS AVAILABLE.

    Patient problems: Intracranial Hemorrhage

    MAUDE report 15944282 ↗
  • MalfunctionNov 19, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    MEDTRONIC RECEIVED INFORMATION THAT A AXIUM COIL WAS STUCK IN A PHENOM CATHETER. AFTER THE TWO PRIME 3D 5×15 WAS INSERTED AND REMOVED FROM MICROCATHETER, THE THIRD PRIME 3D 5×15 WAS INSERTED BUT IT GOT STUCK NEAR IN THE MIDDLE OF THE CATHETER. THE CATHETER RESISTANCE WAS IN THE SHAFT CENTER. THE CATHETER AND COIL WERE NOT DAMAGED. THE CATHETER WAS FLUSHED AS PER INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE ANTERIOR CEREBRAL ARTERY (ACA). THE MAX DIAMETER WAS 10MM AND THE NECK DIAMETER WAS 5MM. BLOOD FLOW SPEED WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL DIAMETER WAS 2.5MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ANCILLARY DEVICES: SYNCHRO SELECT GUIDEWIRE, PRIME 3D 5×15 2 PIECES EMBOLIZATION COIL ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15830509 ↗
  • MalfunctionSep 24, 2022Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE HUB OF THE CATHETER. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15480472 ↗
  • MalfunctionMay 21, 2022Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

    MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD RESISTANCE, IN THE ECHELON CATHETER, DETACHED PREMATURELY, AND WAS STRETCHED. AFTER THE MICROCATHETER REACHED THE ANEURYSM, THE SURGEON STARTED FILLING THE COIL. THE 3DCOIL OF APB-5-15 WAS THE FIRST TO BE SELECTED, AND PLANNED TO FORM A HOOP. AFTER TAKING OUT THE COIL AND HYDRATING IT, THE COIL STARTED TO BE DELIVERED. BEFORE THE COIL CAME OUT OF THE TIP OF THE MICROCATHETER, IT WAS FOUND THAT THE RESISTANCE WAS TOO LARGE TO BE DELIVERED IN. AT THAT TIME, ONLY PART OF THE PUSH ROD WAS DELIVERED INTO THE MICROCATHETER. AFTER FINDING THAT THE RESISTANCE WAS TOO LARGE, THE SURGEON WAS WORRIED ABOUT SAFETY AND DID NOT CONTINUE THE DELIVERY, AND STOPPED FOR 30 SECONDS. THE SURGEON INJECTED NORMAL SALINE INTO THE MICROCATHETER, AND CONTINUED TO PUSH, BUT THE RESISTANCE WAS STILL VERY LARGE. THEN, THE COIL BODY AND PUSH ROD WERE BROKEN DURING THE SURGEON'S WITHDRAWAL THE COIL PROCESS. THE SURGEON FINALLY WITHDREW THE COIL BODY FROM THE INTRODUCER SHEATH, AND THE COIL HAD BEEN STRETCHED DURING THE WITHDRAWAL PROCESS. DURING THE DELIVERY PROCESS, PART OF THE COIL ENTERED INTO THE MICROCATHETER AND IT HAD NOT YET CAME OUT FROM THE TIP, SO

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14466176 ↗
  • InjuryMar 23, 2022Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

    MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL DETACHED PREMATURELY IN THE MICROCATHETER AND IT MIGRATED INTO THE MIDDLE CEREBRAL ARTERY, CAUSING AN OCCLUSION. THE PATIENT WAS BEING TREATED FORM A RUPTURED SACCULAR ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 8MM AND THE NECK DIAMETER WAS 6MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. WHILE ATTEMPTING TO PLACE THIS AXIUM COIL, THE MICROCATHETER KICKED OUT OF THE ANEURYSM. THE PHYSICIAN RODE THE MICROCATHETER OVER THE COIL TO RE-ENTER THE ANEURYSM. ONCE BACK INSIDE THE ANEURYSM HE NOTICED THE COIL WAS NOT MOVING WITH MULTIPLE ATTEMPTS TO ADVANCE OR WITHDRAW. HE THEN NOTICED THE COIL HAD DETACHED FROM THE MICROCATHETER EARLY. AN ATTEMPT WAS MADE WITH A TULIP SNARE TO SNARE THE COIL BUT THIS WAS UNSUCCESSFUL AND THE COIL MIGRATED INTO THE MIDDLE CEREBRAL ARTERY, CAUSING AN OCCLUSION. A SOLITAIRE WAS THEN DEPLOYED ACROSS THE COIL AND RETRACTED INTO A GUIDE CATHETER UNDER ASPIRATION TO SUCCESSFULLY REMOVE THE COIL FROM THE PATIENT. THE COIL WAS REMOVED FROM THE PATIENT WITH A SOLITAIRE. COIL WAS REMOVED VIA A SOLITAIRE AND PATIENT WAS PLACED ON BLOOD THINNERS DUE TO THE OCCLUSION THE COIL

    Patient problems: Obstruction/Occlusion

    MAUDE report 13866723 ↗
  • MalfunctionMay 3, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    ADDITIONAL INFORMATION RECEIVED REPORTED NO DETACHMENT ATTEMPTS HAD BEEN MADE. NO PUSHWIRE DAMAGE WAS OBSERVED. THE COIL WAS REMOVED AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11760558 ↗
  • InjuryFeb 2, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

    MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT DETACH, EVEN AFTER USE OF THE MANUAL DETACHMENT METHOD. HOWEVER, THE COIL THEN DETACHED IN THE CATHETER DURING RETRIEVAL AND HAD TO BE RETRIEVED USING A SNARE. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR BASILAR TOP ANEURYSM. IT WAS NOTED THAT THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THE ANEURYSM AND VESSEL CHARACTERISTICS WERE UNKNOWN. FOUR OR MORE DETACHMENT ATTEMPTS WERE MADE, AND A SECONDARY INSTANT DETACHER WAS USED WITHOUT RESOLVE. ONE MANUAL DETACHMENT ATTEMPT WAS MADE. THERE WERE NO RELATED PATIENT SYMPTOMS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11267512 ↗
  • MalfunctionOct 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PATIENT IS RECOVERING FROM THE PROCEDURE WITHOUT INCIDENT, AND THERE WERE NO ADVERSE EVENTS.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

    MAUDE report 10639966 ↗
  • MalfunctionFeb 10, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

    MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT THESE ALL FIVE COILS WERE PLACED ON THE MICROCATHETER AND COILS DID NOT PASS THROUGH SO MAKING IMPOSSIBLE TO EMBOLIZED THE ANEURYSM. THE PATIENT UNDERWENT COILING TREATMENT FOR AN UNRUPTURED ANEURYSM. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE VESSEL WAS NORMAL TORTUOUS. NO PATIENT INJURY WAS REPORTED. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. NO IMAGES AVAILABLE FOR REVIEW. YES, THE CATHETER WAS FLUSHED AS INDICATED PER THE IFU. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9688689 ↗
  • InjuryFeb 14, 2019Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

    MEDTRONIC RECEIVED A REPORT OF AXIUM COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ISCHEMIC STROKE. DURING THE PROCEDURE, A VESSEL WAS PERFORATED WITH A NON-MEDTRONIC GUIDEWIRE AS THE PHYSICIAN WAS ATTEMPTING TO CROSS THE CLOT. THE PHYSICIAN ATTEMPTED TO PLACE AN AXIUM COIL THROUGH THE MICROCATHETER IN THE AREA OF THE PERFORATION, BUT IT DID NOT DETACH CORRECTLY. THE TECHNICIAN DESCRIBED THE COIL MALFUNCTION AS ¿PARTIALLY DETACHED¿ AND TRIED TO RECAPTURE IT BUT WAS UNABLE TO AT FIRST. A WIRE WAS PLACED TO PUSH THE COIL OUT BUT BECAME TANGLED. THE COIL WAS EVENTUALLY ABLE TO BE RETRIEVED. THERE WERE NO FURTHER REPORTS OF PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8340562 ↗
  • InjuryNov 20, 2018Detachment of Device or Device Component; Unintended Movement; Detachment of Device or Device Component; Unintended Movement

    MEDTRONIC RECEIVED REPORT OF COIL PREMATURE DETACHMENT. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, AMORPHOUS, ANEURYSM IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK WAS 3MM. THE BLOOD FLOW WAS NORMAL. THE ANATOMY WAS SEVERELY TORTUOUS. DURING THE PROCEDURE, ONE OR TWO NON-MEDTRONIC COILS WERE PLACED. AFTERWARD, REPORTED AXIUM COIL WAS ATTEMPTED TO BE PLACED; BUT THE COIL UNINTENTIONALLY DETACHED, AND A LOOSE COIL LOOP WAS IN THE PARENT VESSEL. THE COIL HAD BEEN REPOSITIONED ONCE. THIS EVENT REQUIRED A STENT AND DUAL ANTIPLATELET THERAPY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8089578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

  • Z-0874-2012 · Mar 1, 2010 · Terminated
    Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
  • Z-0873-2012 · Mar 1, 2010 · Terminated
    Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab

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Sources and updates

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