Axium Detachable Coil System QC-3-8-3DRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00847536037700), received between Mar 23, 2022 and Oct 28, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT HAD AN ANEURYSM IN THE RIGHT INTRACRANIAL OPHTHALMIC ARTERY SEGMENT. AFTER THE MICROCATHETER WAS IN PLACE, SPRING COILS WERE INSERTED ONE BY ONE. WHEN INSERTING THE SECOND SPRING COIL QC-4-8-3D, IT WAS FOUND THAT THE MICROCATHETER HAD GREAT RESISTANCE AND REPEATED PUSHES COULD NOT SUCCESSFULLY IMPLANT IT. THE SURGEON SUGGESTED REPLACING THE MICROCATHETER WITH THE NEW ONE, AND THEN THE QC-4-8-3D WAS SUCCESSFULLY IMPLANTED. AFTER THAT, THE QC-3-8-3D WAS DELIVERED, BUT IT WAS FOUND THAT THE SPRING COIL DELIVERY RESISTANCE WAS VERY LARGE AND THE PUSH ROD WAS KINKED. AFTER THAT, SPRING COIL OF OTHER BRAND WAS USED INSTEAD AND THE OPERATION WAS SUCCESSFULLY COMPLETED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WAS CATHETER RESISTANCE IN THE MIDDLE OF THE MICROCATHETER. THERE WAS PUSHER KINK/BROKEN. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE PROXIMAL SEGMENT WAS DAMAGED. THE PATIENT WAS UNDERGOING INTRACRANIAL ANEURYSM EMBOLIZATION SURGERY FOR TREATMENT OF A SACCULAR, RUPTU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407158 ↗
• MalfunctionOct 15, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT AN UNRUPTURED, SACCULAR ANEURYSM LOCATED AT THE LEFT POSTERIOR COMMUNICATING ARTERY, THE BARE AXIUM 3D COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SLEEVE DURING DELIVERY. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 3.2 MILLIMETERS AND A NECK DIAMETER OF 2.5 MILLIMETERS. BLOOD FLOW AND VESSEL TORTUOSITY WERE DESCRIBED AS NORMAL. THE DEVICE WAS NEVER IMPLANTED AND WAS REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294911 ↗
• MalfunctionJun 9, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON MARCH 24, 2025, THE HEALTHCARE PROVIDER (HCP) PERFORMED TREATMENT FOR ANTERIOR COMMUNICATING ARTERY ANEURYSM. AFTER PUNCTURE, THE ECHELON10 MICROCATHETER WAS INSERTED TO THE LESION SITE. THE FIRST SPRING COIL WAS QC-3-8-3D. WHEN PREPARING FOR HYDRATION, THE SPRING COIL COULD NOT BE PUSHED OUT OF THE PROTECTIVE SHEATH. AFTER MULTIPLE ATTEMPTS, IT STILL COULD NOT BE PUSHED OUT. HCP REPLACED IT WITH THE SPRING COIL OF THE SAME MODEL, HYDRATED IT, AND FILLED THE ANEURYSM. AFTER FILLING, SELECTED THE SECOND SPRING COIL APB-2-6-HX-ES. AFTER FILLING, SELECTED TWO SPRING COILS APB-2-4-3D-ES AND APB-1-3-3D-ES SUCCESSIVELY. AFTER FILLING, PERFORMED ANGIOGRAPHY OF THE SPRING COIL, FILLED DENSELY, WITHDREW THE SPRING COIL AND MICROCATHETER, AND THE OPERATION WAS COMPLETED. THERE WAS COIL RESISTANCE/STUCK IN SHEATH. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. 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 ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171152 ↗
• MalfunctionMar 28, 2025Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL STRETCHED AND COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE C6 SEGMENT OF RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4MM AND A 2.1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER DISASSEMBLING A DETACHABLE SPRING COIL (QC-3-8-3D/227569951), IT WAS STRETCHED AND COULD NOT BE DETACHED DURING THE SURGERY. AFTER REOPENING ANOTHER DETACHABLE SPRING COIL (QC-3-8-3D/227569951), THE SURGERY WENT SMOOTHLY. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 3 TIMES AND 2 TIMES WITH A SECOND DETACHER. MANUAL ATTEMPT AT DETACHMENT WAS TRIED TWICE. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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 21718507 ↗
• MalfunctionJan 2, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A RUPTURED SACCULAR INTERNAL CAROTID ARTERY (ICA) ANEURYSM, AN AXIUM COIL WAS STUCK IN THE SHEATH. IT WAS NOTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE ANEURYSM HAD A MAXIMUM DIAMETER OF 4MM AND A NECK DIAMETER OF 2MM. VESSEL TORTUOSITY WAS MODERATE AND BLOOD FLOW WAS NORMAL. THE PATIENT EXPERIENCED NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICE: ECHELON MICROCATHETER ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL ACCIDENTALLY BROKE DURING THE PROCEDURE, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063991 ↗
• MalfunctionJan 24, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE AXIUM COIL WAS TAKEN OUT, IT WAS FOUND THAT THE PUSHER WAS KINKED. THE AXIUM COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). 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 LEFT ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 4MM NECK D IAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. IT WAS NOTED THAT THE PUSHER WAS FOUND TO BE KINKED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18574376 ↗
• MalfunctionJan 22, 2024Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL STRETCHED AND SEPARATED/BROKE/PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY (ICA) COMMUN ICATING SEGMENT WITH A MAX DIAMETER OF 4.2 MM AND A 2.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE QC-3-8-3D DETACHABLE SPRING COIL STRETCHED DURING THE OPERATION. IT WAS REPORTED THE COIL SEPARATED/BROKE/ PREMATURE DETACHMENT OCCURRED. THE IMPLANT COIL WAS REMOVED FROM THE PATIENT BY PULLING BACK ON THE PUSH ROD AND SLOWLY REMOVING THE COIL. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553055 ↗
• MalfunctionNov 9, 2023Separation Failure; Material Deformation; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE FOUND. THE PUSHWIRE WAS KINKED AFTER REMOVAL FROM THE PATIENT. THE INSTANT DETACHERS WERE FROM CONSIGNMENT STOCK AND CUSTOMER OWNED. THE LAST CYCLE COUNT WAS A MONTH AGO AND ARE CONDUCTED MONTHLY. THE DOCTOR GAVE PRIORITY TO MANUAL DETACHMENT KNOWING THAT THE DETACHER HAD EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102920 ↗
• MalfunctionJul 31, 2023Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE TIP END OF THE IMPLANT COIL WAS STRETCHED. IT WAS ALSO NOTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. THE COIL WAS REMOVED FROM THE PATIENT BY RETRACTING INTO THE MICROCATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. IT WAS UNKNOWN IF THERE WAS ANY FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. IT WAS UNKNOWN OF THE PHYSICIAN REPOSITIONED THE COIL, ATTEMPTED TO DETACH THE COIL OR IF THEY ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ENTIRE COIL WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17428255 ↗
• MalfunctionDec 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS GREAT RESISTANCE OF BOTH COILS AND THEY WERE STUCK IN THE SHEATH AND COULDN'T COME OUT. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF WHICH WAS UNKNOWN. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED DURING PREPARATION, 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 16035209 ↗
• MalfunctionJun 27, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL WAS STUCK IN THE PROXIMAL SECTION OF AN ECHELON MICROCATHETER. THE PATIENT WAS BEING TREATED FOR A SACCULAR, RUPTURED ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA). THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 1MM. PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL DIAMETER WAS 4MM. THE DEVICES WERE PREPARED AS ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE IMPLANT COIL PUSHED SMOOTHLY OUT OF THE SHEATH. THERE WAS NO COIL OR CATHETER DAMAGE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837498 ↗
• MalfunctionMar 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SPRING COIL WAS PUSHED OUT OF THE PROTECTIVE SHEATH, IT WAS FOUND THAT THE COIL HAD ALREADY FALLEN OFF. 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). THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE POSTERIOR COMMUNICATING SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861834 ↗

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