AxiumTM QC-1.5-2-HELIX (UDI 00847536029415)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536029415), received between Oct 18, 2019 and Feb 21, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2022Break; Stretched; Material Deformation; Break; Stretched; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE COIL WAS USED, IT WAS STRETCHED. DURING THE WITHDRAWAL PROCESS, THE TWO COILS WERE STUCK T OGETHER IN THE MICROCATHETER, WHICH MEANT THE TWO COILS HAD TO BE SCRAPPED TOGETHER. AFTER DRAGGING THE TWO COILS OUT, TWO NEW COILS WERE USED AND THE ANEURYSM FILLING WAS SUCCESSFULLY COMPLETED. THE COILS WERE SEPARATED/BROKEN/PREMATURELY DETACHED BUT THEY WERE ABLE TO BE DRAGGED OUT THROUGH THE MICROCATHETER. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS BENT/BROKEN AND THAT WAS NOT INTENTIONAL. THERE WAS FRICTION/DIFFICULTY DURING THE DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 1 TIME. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A IRREGULAR, UNRUPTURED ANEURYSM IN THE LATERAL WALL OF THE RIGHT INTERNAL CAROTID ARTERY COMMUNICATING SEGMENT WITH A MAX DIAMETER OF 2.7MM AND A 1.6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573115 ↗
• MalfunctionFeb 21, 2022Break; Stretched; Material Deformation; Break; Stretched; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE COIL WAS USED, IT WAS STRETCHED. DURING THE WITHDRAWAL PROCESS, THE TWO COILS WERE STUCK TOGETHER IN THE MICROCATHETER, WHICH MEANT THE TWO COILS HAD TO BE SCRAPPED TOGETHER. AFTER DRAGGING THE TWO COILS OUT, TWO NEW COILS WERE USED AND THE ANEURYSM FILLING WAS SUCCESSFULLY COMPLETED. THE COILS WERE SEPARATED/BROKEN/PREMATURELY DETACHED BUT THEY WERE ABLE TO BE DRAGGED OUT THROUGH THE MICROCATHETER. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS BENT/BROKEN AND THAT WAS NOT INTENTIONAL. THERE WAS FRICTION/DIFFICULTY DURING THE DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 1 TIME. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A IRREGULAR, UNRUPTURED ANEURYSM IN THE LATERAL WALL OF THE RIGHT INTERNAL CAROTID ARTERY COMMUNICATING SEGMENT WITH A MAX DIAMETER OF 2.7MM AND A 1.6MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573028 ↗
• MalfunctionMar 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE AXIUM COIL WAS PUSHED HALFWAY INTO THE ANEURYSM, IT SUDDENLY DETACHED AUTOMATICALLY FOR NO REASON. THE PROBLEM DID NOT OCCUR AFTER REPLACING THE COIL. IT WAS NOTED THE COIL WAS IMPLANTED AT THE INTENDED LOCATION AND REMAINED IN THE PATIENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, THE COIL PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION DURING DELIVERY, NO DETACHMENT ATTEMPTS HAD BEEN MADE, NO ROTATION OF THE PUSHWIRE WAS PERFORMED, A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE, AND IT WAS UNKNOWN IF THE COIL HAD BEEN REPOSITIONED. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11421925 ↗
• MalfunctionSep 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE MIDDLE CEREBRAL ARTERY (MCA) WITH A MAX DIAMETER OF 4.2MM AND A 3.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AUTOMATICALLY DETACHED DURING THE SURGERY. FORTUNATELY, THE COIL WAS ALREADY IN THE ANEURYSM, IMPLANTED IN THE INTENDED LOCATION, AND THEN THE PUSHWIRE WAS WITHDRAWN. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, THE PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION DURING DELIVERY, NO REPOSITIONING OF THE COIL, NO DETACHMENT ATTEMPTS MADE, NO ROTATION OF THE PUSHWIRE, AND A CONTINUOUS FLUSH WAS NOT ADMINISTERED. 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 COOK 6 SHEATH, NAVIEN, ECHELON, SYNCHRO14.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10519005 ↗
• MalfunctionOct 18, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT BARE AXIUM COIL FAILED TO DETACH. TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER (ID). A SECOND ID WAS NOT USED. ONE MANUAL DETACHMENT WAS ATTEMPTED BUT STILL THE COIL FAILED TO DETACH. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE COILING TREATMENT OF AN ANTERIOR CEREBRAL ARTERY ANEURYSM. THE ANEURYSM WAS UNRUPTURED, SACCULAR WITH A MAX DIAMETER WAS 5.1MM AND A NECK WIDTH OF 1.2MM. THE BLOOD FLOW AND THE VESSEL ANATOMY WERE BOTH NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9210804 ↗

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