Axium Prime Detachable Coil System APB-1.5-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00763000313661), received between Aug 16, 2022 and Jan 13, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

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.

• MalfunctionJan 13, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN ECHELON 10 MICROCATHETER MET RESISTANCE AT THE DISTAL END OF THE CATHETER WHEN ADVANCED OVER A NEURO GUIDEWIRE. AN AXIUM PRIME BARE COIL WAS DELIVERED THROUGH THE SAME MICROCATHETER, HOWEVER, THE COIL COULD NOT BE SMOOTHLY PUSHED OUT OF THE MICROCATHETER. THE INTERMEDIATE CATHETER WAS RAISED AND ADDITIONAL TENSION WAS APPLIED, BUT THE PROBLEM PERSISTED. SUBSEQUENTLY, BOTH THE MICROCATHETER AND COIL WERE REPLACED WITH NEW MEDTRONIC ONES TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT MIDDLE CEREBRAL ARTERY WITH A MAX DIAMETER OF 2.44 MM AND A 1.45 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. FEMORAL ARTERY ACCESS VESSEL DIAMETER WAS 4.12 MM. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION WAS RECEIVED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO KINK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053573 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE ANEURYSM FILLING PROCESS, THE COIL WAS ACCIDENTALLY DETACHED IN THE MICROCATHETER. THE COIL WAS IN THE MICROCATHETER AND THE MICROCATHETER WAS DISCARDED BY THE DOCTOR. 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, UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3*2 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883728 ↗
• MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE OBSERVED ON THE PUSHWIRE REGARDING THE APB-1.5-4-3D-ES. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY REGARDING TO APB-1-2-3D-ES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22088928 ↗
• MalfunctionMar 24, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS ENCOUNTERED ISSUES. THE TAIL END OF THE APB-2-8-HX-ES SPRING COIL WAS STRETCHED AND SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. THE APB-1.5-4-3D-ES SPRING COIL COULD NOT BE DETACHED AND WAS SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. THE PHYSICIAN MADE 2 ATTEMPTS TO DETACH THE COIL WITH THE INSTANT DETACHER. THEY DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS 1 MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. THERE WERE NO ISSUES REPORTED 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. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679029 ↗
• InjuryJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant

  MAUDE report 21079463 ↗
• MalfunctionDec 6, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PRIOR TO COIL NON-DETACHMENT; NO ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED. CONTINUED ISSUE WITH AXIUM COIL RESISTANCE ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873065 ↗
• MalfunctionDec 2, 2024Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. IT IS UNKNOWN HOW MANY ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THE MANUAL METHOD WAS ATTEMPTED SEVERAL TIMES. PRIOR TO COIL NON-DETACHMENT, NO ISSUES ENCOUNTERED. IT WAS UNKNOWN IF ANY PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT. THERE WAS SOME RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821336 ↗
• MalfunctionNov 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL ENCOUNTERED RESISTANCE. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RIGHT CAVERNOUS SEGMENT OF INTERNAL CAROTID ARTERY WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 4.81 MM AND NECK DIAMETER 2.66 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL TORTUOSITY WAS MINIMAL. THE SPRING COIL HAS A LARGE RESISTANCE WHEN IT WAS DELIVERED TO THE MICROCATHETER PORT MULTIPLE TIMES. THE MICROCATHETER ENTERED THE ANEURYSM CAVITY WITH THE GUIDEWIRE. THE FIRST QC-4-8-3D WAS DELIVERED TO THE MICROCATHETER PORT THROUGH THEY VALVE, WHICH HAD A LARGE RESISTANCE. IT WAS DELIVERED SEVERAL TIMES BUT IT WAS AGAINST THE CATHETER. TO PREVENT ACCIDENTS, THE SURGEON REPLACED IT WITH AN ACHIEVA'S COIL, AND IT WAS DELIVERED NORMALLY THIS TIME. THEN THE SURGEON USED OUR COMPANY'S COILS AND SUCCESSFULLY FILLED 3 COILS. WHEN DELIVERING APB-1.5-4-3D-ES AND APB-1-3-HX-ES, THEY STILL COULD NOT ENTER THE MICROCATHETER. THE SURGEON REPLACED IT WITH AN ACHIEVA'S COIL, AND THE EMBOLIZATION WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740624 ↗
• MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE COIL PREMATURE DETACHMENT AND CATHETER DAMAGE WAS NOT DETERMINED. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906734 ↗
• MalfunctionMar 29, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WERE STRETCHED.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 4MM AND A 2MM 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 FOR ANEURYSM EMBOLIZATION, AFTER THE COIL WAS FORMED A HOOP, USED APB-2-3-HX-ES COIL TO FILL, THE COIL WAS STRETCHED, REPLACED WITH ANOTHER APB-1.5-4-3D-ES COIL, AND THE TAIL END WAS STRETCHED, REPLACED WITH OTHER SPECIFICATIONS OF THE COIL TO COMPLETE THE OPERATION SUCCESSFULLY. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NEW INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16635097 ↗
• MalfunctionFeb 10, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT AND AXIUM COIL COULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT MIDDLE CEREBRAL ARTERY WITH A MAX DI AMETER OF 5 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL WAS NOT DETACHED IN MICRO CATHETER. THE DOCTOR TRIED TO DETACH MANY TIMES USING THE I.D AND MANUAL DETACHMENT METHOD, HOWEVER FAIL. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER FIVE TIMES. THE PHYSICIAN TRIED TO DETACH THE COIL WITH ANOTHER INSTANT DETACHER THREE TIMES. THERE WAS A MANUAL ATTEMPT MADE AT DETACHMENT VIA HYPOTUBE TWO TIMES. 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 FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A PHENOM 17 2X, 2R MICROCATHETER AND SYNCHRO14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353559 ↗
• MalfunctionAug 16, 2022Packaging Problem; Packaging Problem

  MEDTRONIC RECEIVED INFORMATION THAT A AXIUM COIL WAS NOT THE SIZE OF THE OUTER PACKAGE. THE PATIENT WAS BEING TREATED FOR AN ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 2MM AND THE NECK DIAMETER WAS 3MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THE COIL WAS PUSHED OUT FROM THE MICROCATHETER WITH A VERY SHORT LENGTH, IT WAS NOT THE OUTER PACKAGE SIZE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234494 ↗