AxiumTM QC-3-8-HELIX (UDI 00847536029569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536029569), received between Aug 27, 2020 and Aug 25, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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.

• MalfunctionAug 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE SOLITAIRE AB. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365385 ↗
• MalfunctionMay 3, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE COIL WAS DEPLOYED, IT COULD NOT BE DETACHED. TWO DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHER, ONE ATTEMPT WAS MADE WITH A SECOND INSTANT DETACHER, AND NO MANUAL DETACHMENT ATTEMPTS WERE MADE. IT WAS STATED THERE WAS NO ISSUE WITH THE INSTANT DETACHERS. A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE. 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 AN UNSPECIFIED ANEURYSM WITH A MINIMAL VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER, SYNCHRO 2 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759868 ↗
• MalfunctionDec 30, 2020Separation Failure; Material Deformation; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO THE COIL NON-DETACHMENT, THERE WERE NO ISSUES WITH THE COIL. IT WAS NOTED THAT THE PUSHWIRE WAS DAMAGED. THE INSTANT DETACHER THAT WAS USED WAS FROM THE DOCTOR'S STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095263 ↗
• MalfunctionOct 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE SL-10 MICROCATHETER WAS PLACED INSIDE THE ANEURYSM. ONE HELIX COIL WAS DEPLOYED. LATER, THE REPORTED COIL WAS DELIVERED, BUT WHILE PUSHING INTO THE MICROCATHETER HUB, IT PREMATURELY DETACHED. NO FORCE WAS APPLIED, BUT THE COIL WAS STILL FOUND DETACHED. THERE WAS NO DAMAGE TO THE PUSHWIRE OR CATHETER, NO FRICTION WAS EXPERIENCED, NO REPOSITIONING OF THE COIL OR ROTATION OF THE PUSHWIRE WAS PERFORMED, NO DETACHMENT ATTEMPTS WERE MADE, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE COIL WAS TAKEN OUT, AND ANOTHER COIL WAS THEN USED TO FINISH THE CASE. 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 AN AMORPHOUS, RUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 5 MM AND A 3.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A NEURON MAX SHEATH, NEURON 6F GUIDECATHETER, SL-10 MICROCATHETER, SYNCHRO GUIDEWIRE.

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

  MAUDE report 10653767 ↗
• MalfunctionAug 27, 2020Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DEPLOYMENT, IT WAS DEPLOYED BY HAND FOLDING. THE WIRE COULD NOT BE PULLED, NOR COULD IT BE PULLED WITH THE TWEEZERS. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. 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, RUPTURED ANEURYSM OF THE C5 SEGMENT WITH A MAX DIAMETER OF 5MM AND A 3.7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE COIL FAILED TO DETACH WITHIN THE TARGET LOCATION. THE CATHETER THAT WAS USED WAS NOT A MEDTRONIC CATHETER. THE MODEL AND LOT NUMBERS WERE NOT PROVIDED. NO RESISTANCE WAS FELT. NO DAMAGE WAS NOTICED WITH THE COIL. THE DEVICE IS CURRENTLY WITH THE DISTRIBUTOR. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT MANUAL DETACHMENT WAS ATTEMPTED THREE TIMES WITHOUT SUCCESS; NO ATTEMPTS WERE MADE TO USE AN INSTANT DETACHER PER THE SURGEON'S PREFERENCE. THE REPLACEMENT COIL WAS SUCCESSFULLY DETACHED BY MANUAL DETACHMENT METHOD. CATHETER CO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10460761 ↗

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