Axium QC-7-20-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00836462010406), received between Aug 19, 2019 and Nov 1, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PRODUCT WAS PREPARED AND INSERTED INTO THE ANEURYSM AS PER THE PACKAGE INSERT, THE COIL WAS COMPLETELY INSERTED. DETACHMENT WAS TRIED USING ID-1 BUT DETACHMENT WAS NOT POSSIBLE. EVEN WHEN ID-1 WAS USED 3 TIMES AND THEN REPLACED WITH ANOTHER LOT, DETACHMENT WAS STILL NOT POSSIBLE. EMERGENCY DETACHMENT WAS TRIED, BUT IT STILL COULD NOT BE DETACHED, SO IT WAS COLLECTED USING A SNARE. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES; 3 TIMES WITH THE INITIAL INSTANT DETACHER AND ONCE AGAIN WITH ANOTHER LOT. THERE WAS ONE MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. IT WAS UNKNOWN IF THERE WAS ANY ISSUE WITH THE INSTANT DETACHER. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. 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 LEFT IC-PC ANEURYSM WITH A MAX DIAMETER OF 8 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A 6F FR FUBUKI GUIDE CATHETER, SL-10 STR MICROCATHETER, A CHIKAI14 200 CM GUIDEWIRE AND SYOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709735 ↗
• MalfunctionMay 20, 2022Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THEY WERE ATTEMPTING TO DETACH THE COIL WITH THE DETACHER AND THE MANUAL METHOD AND NEITHER WORKED. THE COIL WAS REMOVED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH THE COIL WITH ANOTHER INSTANT DETACHER. THE MANUAL METHOD WAS ATTEMPTED 3 TIMES AS WELL. 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 ANEURYSM IN THE BASILAR WITH A MAX DIAMETER OF 10MM AND A 5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462523 ↗
• MalfunctionApr 1, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THREE AXIUM COILS DID NOT DETACH INITIALLY. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED AMORPHOUS ANEURYSM IN THE ACOMM LOCATION. THE MAX DIAMETER WAS 9MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS SEVERE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  THE MICROCATHETER WAS A COMPETITOR'S PRODUCT. THE COILS WERE DETACHED. WHEN PULLING BACK THE PUSHER WIRE THE DETACHER MARKER ON THE PUSHER WIRE MOVED BACK AND THE COIL DIDN'T. THEN AFTER ABOUT 1 CM THE COIL STARTED TO COME BACK WHEN PULLING THE PUSHER WIRE. REPOSITIONED THE MICROCATHETER DISTALLY AND PROXIMALLY. AND TRIED DETACHING 2 MORE TIMES. THEN BROKE THE PUSHER WIRE. AND STILL THE COIL WOULD COME BACK AFTER PULLING BACK THE PUSHER. EVENTUALLY THE COIL DETACHED AFTER THE MICROCATHETER MOVED AND PUSHERWIRE PUSHED PULLED NUMEROUS TIMES. THE PHYSICIAN ATTEMPTS TO DETACH THE COIL WITH THE INSTANT DETACHER 4 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. 2 MANUAL ATTEMPTS WERE MADE VIA A HYPOTUBE. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979869 ↗
• MalfunctionDec 23, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS PREMATURE DETACHMENT WITH THE AXIUM COIL. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION DURING DELIVERY. THE COIL WAS REPOSITIONED, BUT DID NOT ATTEMPT TO DETACH THE COIL. THE DELIVERY PUSHER WAS ROTATED DURING THE PROCEDURE AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A ENVOYDA6F GUIDE CATHETER AND SL10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078859 ↗
• MalfunctionAug 19, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT TWO BARE AXIUM COILS FAILED TO BE DETACHED. QC-7-20-3D: 5 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER; 2 ADDITIONAL DETACHMENT ATTEMPTS WERE MADE WITH A SECOND INSTANT DETACHER AND 2 MANUAL DETACHMENTS. QC-8-30-3D: 3 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER; 3 ADDITIONAL DETACHMENT ATTEMPTS WERE MADE WITH A SECOND INSTANT DETACHER AND 2 MANUAL DETACHMENTS. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907715 ↗

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-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
• 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