Axium Prime Detachable Coil System APB-5-15-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536038271), received between Dec 28, 2021 and Aug 12, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.

• MalfunctionAug 12, 2026Stretched; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222819 ↗
• MalfunctionApr 21, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY IN THE ECHELON 10 MICROCATHETER. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INTERNAL CAROTID ARTERY (ICA) C7 SEGMENT UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 12 MM AND THE NECK DIAMETER WAS 4.5 MM. PATIENT'S BLOOD FLOW WAS NORMAL; VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AND CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL COULD NOT BE ADVANCED THROUGH THE MICROCATHETER DESPITE MULTIPLE ATTEMPTS. THE SYSTEM WAS REMOVED AND BOTH DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24948504 ↗
• InjuryApr 10, 2024Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION OF THE CATHETER. IT WAS REPORTED THAT AFTER THE MICROCATHETER WAS SHAPED, IT WAS SUCCESSFULLY PLACED INTO THE ANEURYSM THROUGH THE GUIDEWIRE. HOWEVER, DURING THE PROCESS OF FILLING THE COIL, IT WAS FOUND THAT THE COIL HAD GREAT RESISTANCE AND THE PUSHING PROCESS WAS NOT SMOOTH. THE FINAL PLAN WAS TO WITHDRAW THE SPRING COIL AND REFILLED COILS. AFTER WITHDRAWING THE SPRING COIL, IT WAS FOUND THAT THE SPRING COIL HAD BEEN STRETCHED. IT WAS UNCLEAR WHETHER IT WAS A PROBLEM WITH THE MICROCATHETER LUMEN OR THE COIL BODY, SO INTERVENTIONAL TREATMENT WAS FINALLY ABANDONED AND CRANIOTOMY TREATMENT WAS CHANGED INSTEAD. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AND THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083320 ↗
• MalfunctionMay 23, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STRETCHED AND ENCOUNTERED RESISTANCE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE C6 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 4.4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT AFTER THE EMBOLIZATION CATHETER WAS SELECTED INTO THE TUMOR, AND THE INTRACRANIAL STENT WAS HALF-DEPLOYED BY THE STENT CATHETER, A PIECE OF APB-5-15-3D-SS WAS SELECTED TO FORM A HOOP. AFTER THE COIL DELIVERY SHEATH WAS INSERTED INTO THE Y VALVE, A SHORT SECTION OF THE COIL WAS PUSHED AND FOUND THAT IT COULD NOT BE PUSHED, ALSO COULD NOT BE RECOVERED. THEREFORE, AFTER LOOSENING THE Y VALVE AND PUSHING OUT THE EMBOLISM CATHETER TOGETHER WITH THE DELIVERY ROD, IT WAS FOUND THAT A SECTION OF THE COIL WAS STRETCHED. AFTER CUTTING OFF THE STRETCHED SECTION WITH SCISSORS, THE NOT STRETCHED SECTION WAS ALSO STRETCHED. THEREFORE, ANOTHER APB-5-15-3D-SS WAS OPENED AND SUCCESSFULLY INSERTED INTO THE TUMOR. THEN FILLED IN TWO PIECES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988894 ↗
• MalfunctionApr 11, 2023Separation Failure; Unintended Movement; Separation Failure; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THREE ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. ONE ATTEMPT WAS MADE TO DETACH THE COIL USING THE MANUAL METHOD. THERE WERE NO ISSUES WITH THE INSTANT DETACHER. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712532 ↗
• MalfunctionNov 18, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL UNRAVELED IN THE PATIENT AND HAD TO BE REMOVED THROUGH THE MICROCATHETER SYSTEM TO REMOVE AS A WHOLE TO GET THE ENTIRE COIL OUT. NO PATIENT HARM WAS CAUSED THAT WAS KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827995 ↗
• MalfunctionOct 27, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS INITIALLY UNABLE TO BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5.6MM, AND THE NECK DIAMETER WAS 4.4MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT AFTER THE COIL MICROCATHETER WAS IN PLACE, THE FIRST CHOICE WAS THE COIL APB-5-15-3D-SS TO FORM A HOOP. AFTER THE COIL WAS FORMED INTO A HOOP, THE SURGEON CUT OFF THE DETACHMENT POINT AT THE TAIL OF THE COIL, AND THE COIL PUSH WIRE HAD BEEN WITHDRAWN, BUT THE COIL COULD NOT BE DETACHED. AFTER DEBUGGING THE MICROCATHETER AND THE PUSH ROD MANY TIMES, THE COIL STILL COULD NOT BE DETACHED. THE SURGEON TRIED TO DELIVER THE SECOND COIL APB-3-8-HX-ES IN THE COIL MICROCATHETER FOR FILLING. AFTER FILLING, IT WAS DETACHED NORMALLY. A THIRD COIL APB-2-4-HX-ES WAS FILLED, AND IT WAS ALSO DETACHED NORMALLY. THE SURGEON CHOSE TO PLACE THE A SAB-6-20 STENTTO COVER THE ANEURYSM NECK. THE SURGEON ADJUSTED THE MICROCATHETER AND THE PUSH ROD REPEATEDLY. THE FIRST APB-5-15-3D-SS COIL WAS THEN ABLE TO BE DETACHED AND WAS IMPLANTED. THE SURGEON WITHDRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681303 ↗
• MalfunctionAug 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING STENT-ASSISTED COILING FOR A RUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE M2 SEGMENT OF THE RIGHT MIDDLE C EREBRAL ARTERY. THE MAX DIAMETER WAS 4.8MM, AND THE NECK DIAMETER WAS 2.3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE FIRST COIL ENTERED THE ANEURYSM, BUT THE HOOP WAS NOT FORMED IDEALLY. THEREFORE, THE COIL WAS WITHDRAWN. WHEN IT WAS WITHDRAWN ABOUT HALFWAY, IT WAS FOUND THAT THE COIL DID NOT FOLLOW THE PUSH ROD TO GO OUT. CAREFULLY THEY OBSERVED THAT THE COIL WAS AUTOMATICALLY DETACHED, HALF IN THE ANEURYSM, AND HALF IN THE EMBOLIZATION MICROCATHETER. THEY TRIED TO PUSH THE COIL WITH THE DELIVERY ROD, BUT IT COULD NOT BE PUSHED AND THE PUSH ROD WAS WITHDRAWN. ANOTHER COIL WAS ADVANCED IN THE MICROCATHETER AND WAS USED TO PUSH THE PREVIOUS COIL INTO THE ANEURYSM. THIS COIL WAS ALSO SUCCESSFULLY FILLED INTO THE ANEURYSM. THE COILS WERE IMPLANTED IN THE INTENDED LOCATED. TWO MORE COILS WERE IMPLANTED AND FINALLY THE STENT WAS DEPLOYED TO COMPLETE THE SURGERY. THERE WAS NO SPECIAL CASE FOR THE PATIENT. THE PUSHWIRE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324499 ↗
• MalfunctionDec 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT IT WAS BELIEVED THE AXIUM PRIME COIL DETACHED FROM THE DELIVERY SYSTEM DURING ADJUSTMENT IN THE MIC ROCATHETER. THE COIL WAS PULLED OUT OF THE BODY, AND IT WAS FOUND THAT THE COIL HAD DETACHED BUT WAS STILL CONNECTED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN HAD NOT REPOSITIONED THE COIL, AND NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PUSHWIRE WAS NOT ROTATED DURING DELIVERY. NO FURTHER SURGICAL OR MEDICAL INTERVENTIONS WAS NEEDED. 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 AN ANEURYSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13097486 ↗

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