Axium PrimeTM APB-6-20-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536032071), received between Jul 8, 2020 and Jan 5, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2024Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Separation Failure; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. DURING PROCEDURE COIL HAD PREMATURE DETACHMENT INTO MICROCATHETER'S DISTAL PORTION BEFORE COMPLETE THE WALL APPOSITION IN ANEURYSM, THEN PHYSICIAN CAREFULLY REMOVED FULL SYSTEM, GUIDE CATHETER, AND MICRO CATHETER WITH DAMAGE COIL. THEN HEALTHCARE PROVIDER (HCP) CAREFULLY REMOVED ALL SYSTEMS FROM THE PATIENT'S RIGHT MIDDLE CEREBRAL ARTERY (MCA) 1 SEGMENT WITHOUT MOVING FORWARD. THE COIL WAS REMOVED FROM THE PATIENT. THE PUSHWIRE WAS BENT OR BROKEN. THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICAN ATTEMPTED TO DETACH THE COIL 1 TIME WITH THE INSTANT DETACHED. THE PHYSICAN TRIED 2 INSTANT DETACHERS. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED, SACCUALR ANEURYSM IN THE RIGHT MCA. THE MAX DIAMETER WAS 6.7MM AND THE NECK DIAMETER WAS 4.3MM. PATIENT BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: REDIO FUCUS, 7 F, 10 CM SHEATH, ENVOY 6F, 100 CM GUIDE CATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18450358 ↗
• MalfunctionJun 19, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. THE COIL COME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151924 ↗
• MalfunctionFeb 27, 2023Separation Failure; Material Deformation; Physical Resistance/Sticking; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL GOT STUCK IN THE MICROCATHETER IN THE PROXIMAL SECTION.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A NEUROVASCULAR ABNORMALITIES, GRADE 3, LOCATED IN THE ELOQUENT REGION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE DEPLOYING THE COIL, THE DOCTOR FOUND RESISTANCE WHILE PUSHING THE COIL. WHILE WITHDRAWING THE COILING, THE COIL GOT STUCK IN TO THE MICROCATHETER AND THE DOCTOR HAD TO DISCARD THE COIL. THE COIL WAS STUCK IN THE PROXIMAL SECTION OF THE MICROCATHETER. THE IMPLANT COIL PUSHED SMOOTHLY OUT FORM THE INTRODUCER SHEATH. IT WAS UNKNOWN IF THE CATHETER WAS DAMAGED. THE COIL WAS DAMAGED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL GOT SEPARATED. THE CATHETER WAS NOT A MEDTRONIC PRODUCT. THE COIL WAS DISCARDED AS IT GOT SEPARATED IN THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448024 ↗
• MalfunctionFeb 2, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS UNABLE TO BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 2.3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT 3 DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND ANOTHER INSTANT DETACHER WAS TRIED TWICE. THE MANUAL METHOD WAS ATTEMPTED ONE TIME. 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 13429526 ↗
• MalfunctionDec 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO DETACHMENTS HAD BEEN MADE, AND NO KINK/DAMAGE TO THE PUSHWIRE WAS OBSERVED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120304 ↗
• MalfunctionJul 27, 2021Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THE RESISTANCE WAS IN THE DISTAL PART OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12227989 ↗
• MalfunctionJun 9, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM ANEURYSM OF THE RIGHT CAVERNOUS SINUS SEGMENT. THE ANEURYSM MAX DIAMETER WAS 6.4MM AND THE NECK DIAMETER WAS 4.5MM. BLOOD FLOW WAS HIGH. VESSEL TORTUOSITY WAS MINIMAL.  IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THIS WAS THE FIRST COIL USED IN THE PROCEDURE. AFTER FILLING, THE COIL COULD NOT BE DETACHED. 4 UNSUCCESSFUL ATTEMPTS WERE MADE WITH THE INSTANT DETACHER (ID) AND 4 UNSUCCESSFUL ATTEMPTS WERE MADE AT MANUAL DETACHMENT. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966687 ↗
• MalfunctionJul 30, 2020Detachment 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 DETACHED DURING DELIVERY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM OF THE POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 8.26MM AND A 7.06MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THERE WAS LARGE RESISTANCE EXPERIENCED IN THE PROXIMAL SEGMENT OF THE ECHELON MICROCATHETER DURING DELIVERY. AS A RESULT, THE COIL PREMATURELY DETACHED IN IN THE MICROCATHETER. THERE WAS NO DAMAGE OBSERVED TO THE COIL OR CATHETER, AND THE IMPLANT COIL DID NOT PUSH OUT SMOOTHLY FROM THE INTRODUCER SHEATH. 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 AN ECHELON 10 MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10347321 ↗
• MalfunctionJul 8, 2020Break; Break

  MEDTRONIC RECEIVED REPORT THAT AXIUM COIL BROKE DURING DELIVERY INTO THE ANEURYSM. DURING THE TREATMENT OF A POSTERIOR CIRCULATION DISSECTION ANEURYSM, THE SURGEON HALF-DEPLOYED THE LVIS. THE ECHELON CATHETER WAS IN PLACE AND THE AXIUM PRIME COIL (6-20) WAS USED TO FORM A BASKET, WHEN PREPARING TO ADJUST THE COIL TO PUSH BACK THE GUIDEWIRE, IT WAS REVEALED THROUGH THE ANGIOGRAPHY THAT THE COIL HAD BROKEN HALFWAY IN THE ANEURYSM AND HALFWAY IN THE TUBE. THE SURGEON WAS THEN ABLE TO INSERT THE BROKEN PART OF THE COIL INTO THE DISSECTING ANEURYSM WITH A GUIDEWIRE. PART OF THE WITHDRAWN COIL AND PUSHWIRE WILL BE RETURNED TO FOR ANALYSIS. THE COIL WAS PLACED WITHIN THE INTENDED LOCATION. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE PUSHWIRE WAS NOT BROKEN AND WILL BE RETURNED FOR ANALYSIS. THERE WAS NO FRICTION WHEN THE COIL WAS ADVANCED. THE COIL WAS ONLY REPOSITIONED ONE TIME. THE COIL WAS NOT ATTEMPTED TO BE DETACHED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE CUSTOMER WAS NOTIFIED TO RETURN THE DEVICE FOR ANALYSIS. NO PATIENT INJURY OCCURRED. THERE ARE NO IMAGES. THE PATIENT WAS BEING TREATED FOR A BASILAR ARTERY DISSECTION ANEU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10248260 ↗

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