AxiumTM APB-6-20-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536008281), received between Dec 17, 2018 and Mar 21, 2025 — classified as 1 death, 1 injury, 11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY, 6MM. VESSEL TORTUOSITY WAS MODERATE. THE PATIENT WAS RECOVERING WELL FROM THE PROCEDURE AND HAD NO SYMPTOMS IN PARTICULAR RELATED TO THE RESISTANCE AND BROKEN COIL. THE PROCEDURE WAS COMPLETED WITH COIL EMBOLUS. THE CAUSE OF THE RESISTANCE AND BREAK WAS UNKNOWN. CATHETER RESISTANCE OCCURRED AT THE HUB AND THERE WAS A SENSE OF RESISTANCE WHEN THE COIL CAME OUT OF THE INTRODUCER SHEATH. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO KINK/DAMAGE TO THE CATHETER OR PUSHWIRE WAS CONFIRMED. 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 21665328 ↗
• MalfunctionJan 14, 2025Material Too Rigid or Stiff; Separation Failure; Material Deformation; Physical Resistance/Sticking; Material Too Rigid or Stiff; Separation Failure; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL FAILED TO DETACH AND ENCOUNTERED RESISTANCE IN THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED CEREBRAL ANEURYSM WITH A SACCULAR MORPHOLOGY. THE PATIENT¿S VESSEL TORTUOSITY SHOWED NO ANOMALIES. ACCESS VESSEL: A-COM (DIAMETER 2.5 MM). ANEURYSM DIMENSIONS: MAX DIAMETER 14 MM AND NECK DIAMETER 6 MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. FOR THE EMBOLIZATION OF AN UNRUPTURED CEREBRAL ANEURYSM USING A W CATHETER, AN ATLAS (STENT) WAS PLACED WITH THE PHENOM17 STR, FOLLOWED BY FILLING WITH THE PRIMEFRAME10-30 FROM THE JAILED PHENOM17 J. AFTER ALL THE FILLING, NO DETACHMENT OF THE COILS WAS PERFORMED, AND THE PHENOM17 STR WAS TRANS-CELLED TO FILL WITH THE PRIMEFRAME7-30. DURING THE FILLING OF PRIMEFRAME7-30, THERE WAS SLIGHT RESISTANCE, BUT THE COIL WAS DETACHED, AND THE COIL DELIVERY WIRE WAS RETRIEVED. SUBSEQUENTLY, THE AXIUM PRIME3D 6-20 WAS FILLED FROM THE SAME PHENOM17 STR. WHILE THERE WAS NO PROBLEM WITH COIL FILLING, ABNORMAL STIFFNESS WAS FELT WHEN RETRIEVING THE COIL DELIVERY WIRE AFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21150314 ↗
• MalfunctionJan 7, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING THE TREATMENT OF AN UNRUPTURED SACCULAR ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY/POSTERIOR COMMUNICATING ARTERY, THE DETACHMENT OF THE AXIUM PRIME BARE 3D COIL FAILED. THE INITIAL ATTEMPT TO DETACH THE COIL USING THE DETACHMENT HANDLE WAS UNSUCCESSFUL. A MANUAL ATTEMPT TO DETACH THE COIL BY BREAKING THE HYPOTUBE AND PULLING THE SUTURE ALSO FAILED. DESPITE THESE ISSUES, THE COIL WAS REMOVED WITHOUT INCIDENT. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092244 ↗
• MalfunctionJun 27, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT OPENED THE PACKAGE, HYDRATED, DELIVERED THE SPRING COIL, AND AFTER IT WAS IN PLACE, FOUND THAT IT COULD NOT BE DETACHED. WITHDREW AND REPLACED. 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 19624182 ↗
• MalfunctionJun 5, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT RIGHT INTRACRANIAL C7 ANEURYSM. DURING THE SURGERY, THE SURGEON REPORTED THAT IT COULD NOT BE PUSHED SMOOTHLY AND IN THE MICROCATHETER, IT WAS DIFFICULT TO PUSH. AFTER SEVERAL ATTEMPTS, THE OPERATION WAS ABANDONED. AFTER THE SPRING COIL WAS WITHDRAWN FROM THE MICROCATHETER, IT WAS FOUND THAT THE COIL BODY WAS DAMAGED, SO THE COIL WAS REPLACED WITH THE SAME MODEL, PUSHED SMOOTHLY, AND CONTINUED TO COMPLETE THE SURGERY. THE COIL WAS STUCK IN THE DISTAL PORTION OF THE CATHETER. THERE WAS NO DAMAGE OBSERVED TO THE CATHETER. THE IMPLANT COIL WAS DAMAGED. 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. ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER USED WAS AN ECHELON 10 MI CROCATHETER. IT WAS THOUGHT THAT THE COIL WAS DAMAGED DUE TO THE RESISTANCE THAT OCCURRED DURING DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467122 ↗
• MalfunctionSep 15, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL PUSHWIRE WAS STUCK IN THE INSTANT DETACHER (ID). THE DEVICES WERE REPLACED WITH ANOTHER MANUFACTURER'S DEVICES TO COMPLAINT THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO PATIENT OR OTHER PROCEDURE INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15429035 ↗
• DeathJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING 2 AXIUM COILS THAT HAD RESISTANCE. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED BASILAR TIP ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COMPLAINT DEVICES AND ALL ACCESSORIES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS PROPERLY REMOVED FROM THE HOOP AND THERE WAS NO VISIBLE DAMAGE TO THE INTRODUCER SHEATH OR COIL HOOP. ONE COIL (MODEL: APB-6-20-3D-SS, LOT: 220885243) HAD RESISTANCE IN THE SHEATH AND WAS REPLACED. ANOTHER COIL (MODEL: APB-3.5-10-3D-ES, LOT: B173249) HAD THE INTRODUCER SHEATH PROPERLY POSITIONED IN THE HUB AND PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY BUT COULD NOT BE ADVANCED THROUGH THE HUB OF THE CATHETER. IT WAS NOTED THE DISTANCE BETWEEN THE INTRODUCER SHEATH AND THE ANGLED PORTION OF THE NON-MEDTRONIC BALLOON CATHETER WAS TOO GREAT AND THE COIL STARTED TO TAKE COILING SHAPE IN THE HUB OF THE MICROCATHETER. THE COIL WAS DAMAGED BUT THE CATHETER WAS NOT. THE COIL WAS REMOVED AND REPLACED AND OTHER COILS WERE SUCCESSFULLY DELIVERED USING THE SAME CATHETER. IT WAS NOTED

  Patient problems: Intracranial Hemorrhage

  MAUDE report 14633023 ↗
• InjuryApr 1, 2022Stretched; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking; Stretched; Separation Failure; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE DURING DELIVERY IN THE PHENOM CATHETER AND WAS STRETCHED AND DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) WITH ACCESS VIA THE EXTERNAL CAROTID ARTERY (ECA). VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. WHEN DELIVERING THE AXIUM COIL THROUGH THE PHENOM CATHETER, SEVERE TENSION WAS FELT IN THE COIL PUSHWIRE. AN ATTEMPT WAS MADE TO IMPLANT THE COIL BUT IT COULD NOT BE DONE SO THE PHYSICIAN DECIDED TO REMOVE THE COIL. IT WAS NOTED THE PHYSICIAN DID NOT REPOSITION THE COIL. HOWEVER, THE COIL THEN STRETCHED SUDDENLY AND DETACHED UNINTENTIONALLY. THE STRETCHED COIL REMAINED IN THE PARENT ARTERY. THE PATIENT DID NOT HAVE ANY SYMPTOMS OR COMPLICATIONS RELATED TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13978201 ↗
• MalfunctionJul 30, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE AXIUM COIL DID NOT DETACH. IT WAS UNKNOWN IF THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU), OR IF ANOTHER INSTANT DETACHER OR MANUAL METHOD WERE USED. THERE WAS NO HARM/INJURY REPORTED TO THE PATIENT AS A RESULT OF THE EVENT. NO ADDITIONAL DETAILS WERE PROVIDED OR KNOWN AT THE TIME OF THE REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10347068 ↗
• MalfunctionMay 13, 2020Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT BECAME STRETCHED DURING A PROCEDURE CAUSING A LOOP THAT PROTRUDED INTO THE PARENT VESSEL. THE PATIENT WAS BEING TREATED FOR AND UNRUPTURED SACCULAR ANEURYSM OF AN OPHTHALMIC ARTERY SEGMENT. THE ANEURYSM MAX DIAMETER WAS 6MM AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS PREPARED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE. DURING THE FILLING OF THE ANEURYSM WITH THE COIL, THE COIL WAS STRETCHED AND PART OF THE COIL HERNIATED INTO THE BLOOD FLOW VESSEL. A STENT WAS USED TO PRESS THE COIL INTO PLACE IN THE ANEURYSM. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10052374 ↗
• MalfunctionFeb 5, 2020Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED CORRECTION THAT THE IMPLANT COIL DETACHED DETACH FROM THE DELIVERY WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673071 ↗
• MalfunctionAug 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THE AXIUM COIL ACTIVATED EARLY, AFTER NUMEROUS ATTEMPTS TO REPOSITION. NO RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE COIL. THE VESSEL ANATOMY WAS SEVERE IN TORTUOSITY. A REPLACEMENT COIL WAS USED, AND IT COULD NOT BE REPOSITIONED. NO PATIENT INJURY OCCURRED. THE PATIENT WAS BEING TREATED FOR ANEURYSM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925835 ↗
• MalfunctionDec 17, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL WOULD NOT DETACH AS THE PHYSICIAN WAS DETACHING IT URGENTLY. THE PUSHWIRE WAS THEN PULLED BACK BUT IT WAS STILL UNABLE TO BE DETACHED. AFTER THAT, THE DELIVERY PUSHER WAS PUSHED AND THE COIL WAS SOMEHOW PLACED. THE DELIVERY PUSHER WAS COLLECTED IN CASE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. THE PATIENT¿S VASCULATURE WAS MEDIUM IN TORTUOSITY AND THE VESSEL DIAMETER WAS SMALL. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED ANEURYSM MEASURING 7 MM LOCATED IN THE LEFT IC-P.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8169296 ↗

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