AxiumTM QC-8-30-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536030091), received between Jun 24, 2020 and Mar 29, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED ECHELON 10 CATHETER USED MODEL # 105-5091-150, LOT # B450025. THE NAVIEN CATHETER USED MODE #: RFX07 2-115-08MP LOT # B451044. SOLITAIRE AB STENT USED MODEL # SAB-4-30, LOT # B372461. THERE WAS NO DELAY IN TREATMENT WITH THE COMPLICATIONS ENCOUNTERED DURING THE PROCEDURE; TREATMENT WAS COMPLETED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635551 ↗
• MalfunctionAug 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STRETCHED. ANOTHER AXIUM COIL USED IN THE PROCEDURE FELL OFF DURING PUSHING. THE COILS WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A CORONARY ARTERY PULMONARY ARTERY FISTULA. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202640 ↗
• MalfunctionJul 20, 2022Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN ECHELON-10 MICROCATHETER WAS IN PLACE AND A QC-8-30-3D WAS CHOSEN FOR THE FIRST HOOP. AFTER BEING PUSHED OUT IN VITRO, IT WAS FOUND THAT IT COULD NOT BE FORMED A HOOP, AND THEN QC-7-30-3D WAS REPLACED TO FORM A HOOP, AND IT WAS AUTOMATICALLY DETACHED IN THE MICROCATHETER, SO IT WAS COMPLETELY WITHDRAWN. THEY RE-USED THE MICROCATHETER ECHELON-10 (B342204) IN PLACE, SELECTED QC-8-20-3D FOR FORMING A HOOP, AND FILLED IN APB-6-20-3D-SS, APB-3-8--3D-ES, TWO APB-2-4-3D-ES, APB-1.5-4-HX-ES, THE CATHETER TIP WAS WITHDRAWN FROM THE NECK OF THE TUMOR, AND THERE WAS NO MORE FILLING. AFTER ANGIOGRAPHY, THE TUMOR DID NOT DEVELOP, AND THE OPERATION WAS FINISHED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY SEGMENT WITH A MAX DIAMETER OF 8MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070283 ↗
• MalfunctionMar 29, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE MAX DIAMETER AND NECK DIAMETER WERE 8MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT 5 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND 3 ATTEMPTS WERE MADE VIA THE HYPOTUBE. A SECOND INSTANT DETACHER WAS USED, BUT WAS NOT SPECIFIED HOW MANY ATTEMPTS WERE MADE. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. THE COIL WAS REPLACED, AND 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 13943404 ↗
• MalfunctionMar 20, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL FAILED TO DETACH. THE PATIENT WAS BEING TREATED FOR NEUROVASCULAR ABNORMALITIES THAT WAS NOT IN THE ELOQUENT REGION. PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  AFTER DEPLOYING THE COIL FOR ARTERIOVENOUS FISTULA (DAVF), DETACHMENT WAS ATTEMPTED, BUT FAILED. ALSO, MANUAL DETACHMENT DOES NOT WORK, SO USE ANOTHER COIL AFTER RECAPTURE. 3 ATTEMPTS WERE MADE TO DETACH WITH THE INSTANT DETACHER. THE PHYSICIAN DID NOT TRY ANOTHER INSTANT DETACHER, 2 ATTEMPTS WERE MADE WITH THE MANUAL METHOD WITH THE HYPOTUBE. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.  ANCILLARY DEVICES: SL 10 MICROCATHETER, SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13834797 ↗
• MalfunctionNov 10, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STUCK IN THE SHEATH, CATHETER, AND WAS SUSPECTED TO HAVE PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED ANEURYSM. THE MORPHOLOGY WAS TWO SACCULE ABOVE EACH OTHER. THE MAX DIAMETER WAS 8MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT SMALLER ANEURYSM PART WAS COILED FIRST. WHEN THEY STARTED TO OPEN THE COIL IN THE UPPER, BIGGER PART, THE COIL DIDN'T OPEN IN THE CENTER AS EXPECTED. THE COIL WAS REMOVED, AND BECAME STUCK IN THE CATHETER WITH NO MOVEMENT POSSIBLE. THE DEVICES WERE REMOVED, AND THE DOCTOR SUSPECTED THAT THE COIL HAD BEEN DETACHED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. 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 12787929 ↗
• MalfunctionJun 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT THE MEDTRONIC COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER. THE DETACHED COIL WAS REMOVED FROM THE PATIENT INSIDE OF THE MICROCATHETER. A NEW COIL WAS USED WITH THE SAME MICROCATHETER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM MEASURING 8MM X 4.7MM LOCATED IN THE RIGHT ANTERIOR COMMUNICATING ARTERY (ACOM). THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND THE VASCULATURE WAS NORMAL IN TORTUOSITY. THERE ARE NO IMAGES FOR REVIEW. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY AND THE PHYSICIAN DID NOT REPOSITION THE COIL NOR ATTEMPT TO DETACH THE COIL. THE DELIVERY PUSHER WAS NOT ROTATED AND CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

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

  MAUDE report 10188070 ↗

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