Axium Prime Detachable Coil System APB-1-3-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000313807), received between Jun 9, 2023 and Aug 13, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. NO KINK OR DAMAGE TO THE COIL WAS CONFIRMED AFTER REMOVAL, AS THE INFORMATION WAS UNAVAILABLE DESPITE COMMUNICATION WITH THE CUSTOMER. NO KINK OR DAMAGE WAS OBSERVED ON THE PUSHWIRE. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED, AND THE CAUSE OF THE PREMATURE DETACHMENT WAS ALSO NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796046 ↗
• MalfunctionJul 22, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE AND STRETCHING COULD NOT BE DETERMINED. THE COIL EXITED THE INTRODUCER SHEATH SMOOTHLY, AND A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED IN ACCORDANCE WITH THE IFU. IT WAS REPORTED THAT AFTER DETACHMENT, THE SPRING COIL WAS IN A STRETCHED STATE, THOUGH IT COULD NOT BE DETERMINED WHETHER PREMATURE DETACHMENT HAD OCCURRED. THE PROCEDURE WAS NOT COMPLETED AS PLANNED; THE SECOND COIL COULD NOT BE IMPLANTED, SO IT WAS WITHDRAWN AND THE OPERATION WAS ENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564424 ↗
• MalfunctionApr 28, 2025Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE ANEURYSM EMBOLIZATION SURGERY, THE SURGEON DELIVERED THE COIL INTO THE ANEURYSM AND DISCOVERED DURING THE OPERATION THAT THE COIL HAD STRETCHED PREMATURELY. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS REMOVED FROM THE PATIENT WITH OVERALL SLOW WITHDRAWAL. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. 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 21918627 ↗
• 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 THE Y 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 A 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 A ACHIEVA'S COIL, AND THE EMBOLIZATION WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT SYMPTOMS OR CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20740658 ↗
• MalfunctionJun 17, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS LIQUID LEAKAGE WITH A BALLOON, TWO GUIDEWIRES COULD NOT EXIT THE DISTAL END OF THE BALLOON, ONE COIL WAS STRETCHED AND REPLACED WITH A PRODUCT OF THE SAME MODEL AND IMPLANTED SUCCESSFULLY, AND ANOTHER COIL COULD NOT BE DETACHED AND WAS SUCCESSFULLY IMPLANTED AFTER REPLACEMENT. THE REPORTED DEVICES 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 19546979 ↗
• MalfunctionNov 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PREMATURE DETACHMENT WAS UNKNOWN. THE SURGEON REPORTED THAT IT WAS TAKEN OUT NORMALLY AND DELIVERED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171155 ↗
• MalfunctionOct 6, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT WHEN PUSHING THE SPRING COIL, IT WAS FOUND THAT THE TIP WAS DRAWN WIRE, AND THEN TOOK IT OUT. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED C3 ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIA METER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT THE COIL WAS STRETCHED AND THERE WERE NO OTHER ISSUES. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885313 ↗
• MalfunctionJun 9, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM LOCATED IN THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 5.1 MM AND A 3.8 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.  IT WAS REPORTED THAT THE PATIENT UNDERWENT ANEURYSM EMBOLIZATION. THE MICROCATHETER WAS IN PLACE, AND THE COIL  (LOT # 224889205) WAS DETACHED PREMATURELY WHEN THE COIL WAS DELIVERED. IT WAS REPLACED WITHOUT CAUSING INJURY TO THE PATIENT. IT WAS REPORTED COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. IT WAS NOTED THE COIL REMAINS IN THE PATIENT. THE COIL WAS NOT IMPLANTED IN ITS INTENDED LOCATION. IT WAS REPORTED THE STENT ATTACHED TO THE VESSEL WALL IN THE PARENT ARTERY. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. IT IS UNKNOWN IF THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097772 ↗