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

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000313845), received between Jan 10, 2022 and Sep 17, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (5 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.

• MalfunctionSep 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME BARE COIL WAS "UNABLE TO REMOVED". THE PRODUCT WAS REPLACED WITH A MEDTRONIC COIL TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, C7 ANEURYSM WITH A MAX DIAMETER OF 1.5 MM AND A 1.0 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074196 ↗
• MalfunctionMay 13, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AFTER NORMAL HYDRATION, THE MICRO-GUIDEWIRE WAS DELIVERED INTO THE MICRO-CATHETER, BUT IT COULD NOT PASS. AFTER MULTIPLE ADJUSTMENTS, THE MICRO-GUIDEWIRE COULD NOT PASS. THE ONLY OPTION WAS TO REPLACE THE MICRO-CATHETER OF THE SAME BRAND AND MODEL, BUT THE MICRO-GUIDEWIRE STILL COULD NOT PASS. AFTER WITHDRAWING IT FROM THE BODY, IT WAS FOUND THAT THE TIP OF THE MICRO-CATHETER WAS KINKED. FINALLY, THE ONLY OPTION WAS TO REPLACE THE MICRO-CATHETER OF ANOTHER BRAND, AND THE MICRO-GUIDEWIRE PASSED SMOOTHLY. DURING THE FILLING STAGE, THE SPRING COIL APB-1.5-4-HX-ES WAS SELECTED, BUT THE COIL COULD NOT BE PUSHED OUT THE PROTECTIVE SHEATH. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR RIGHT SIDE, OPHTHALMIC ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014824 ↗
• MalfunctionNov 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE COIL STUCK AT THE HUB COULD NOT BE DETERMINED. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. IT WAS NOTED THAT THERE WAS NO VISIBLE DAMAGE TO THE COIL AFTER REMOVAL. THE CATHETER USED WAS AN ECHELON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599654 ↗
• MalfunctionJan 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PUSH ROD COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE RIGHT POSTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 5 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS LOW AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT AFTER THE SPRING COIL EMBOLIZATION WAS COMPLETED, IT WAS SUCCESSFULLY DETACHED, BUT THE SPRING COIL PUSH ROD COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. IN THE END, THE MICROCATHETER AND THE PUSH ROD COULD ONLY BE WITHDRAWN FROM THE BODY TOGETHER; THE MICROCATHETER USED WAS MV COMPANY'S HEADWAY 17. THEY WERE SENT BACK TO THE COMPANY TOGETHER. THIS SURGERY WAS DOUBLE MICROCATHETER EMBOLIZATION, BUT THE SPRING COIL PUSH ROD COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. 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 EVEN T. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE PUSH ROD RESISTANCE WAS NOT DETERMINED. IT WAS NOTED THAT THE RESISTANCE SEEMED TO O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519714 ↗
• MalfunctionMar 16, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO AXIUM COILS HAD POOR VISUALIZATION UNDER X-RAY. DURING THE INTERNAL CAROTID ARTERY (ICA) ANE URYSM TRANS ARTERIAL EMBOLISATION (TAE) PROCEDURE, THE DOCTOR FOUND THE TWO COILS DID NOT HAVE COMPLETE IMAGES UNDER X-RAY THAT CAUSED THE MIS-MEASUREMENT OF THE DETACHED POSITION. THE PARTIAL COIL WAS OUT OF THE ANEURYSM. THE DOCTOR REMOVED THE COIL AND MICROCATHETER. THE PROCEDURE WAS FORCED TO TERMINATE. THE PATIENT WAS STABLE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR ANEURSYM IN THE RIGHT (ICA). THE MAX DIAMETER WAS 13MM AND THE NECK DIAMETER WAS 4.5MM. PATIENT BLOOD FLOW WASN VESSEL TORTUSOITY WAS NORMAL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561146 ↗
• MalfunctionOct 24, 2022Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THERE WERE NO DETACHMENT ATTEMPTS MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663193 ↗
• MalfunctionJul 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM PRIME COIL PREMATURELY DETACHED AND ANOTHER AXIUM COIL USED IN THE PROCEDURE WAS STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE LEFT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4.2MM AND THE NECK DIAMETER WAS 2.3MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT UNDER NORMAL OPERATION AND WITHOUT REPEATED ADJUSTMENT OF THE ANGLE OF THE MICROCATHETER, WHEN THE COIL WAS DEL IVERED TO THE REMAINING 1.5-2MM LENGTH OF THE ANEURYSM, THE COIL WAS ACCIDENTALLY DETACHED. THEY GENTLY PUSHED THE MICROCATHETER TO PUSH THE COIL INTO THE ANEURYSM TO END THE OPERATION. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE HAD BEEN NO FRICTION/DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS HAD BEEN MADE. AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. ANOTHER COIL USED IN THE PROCEDURE HAD BEEN STUCK IN THE SHEATH AND WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917237 ↗
• MalfunctionJan 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT AN AXIUM COIL DETACHED PREMATURELY DURING AN ANEURYSM EMBOLIZATION PROCEDURE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY. IT WAS UNKNOWN IF THE PHYSICIAN REPOSITIONED THE COIL, ROTATED THE PUSHER, OR ATTEMPTED DETACHMENT AT ANY POINT PRIOR TO THE PREMATURE DETACHMENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13210571 ↗