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

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000313838), received between Aug 16, 2022 and Feb 10, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break; Stretched

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307910 ↗
• MalfunctionDec 15, 2025Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT FOR COIL APB-1.5-3-HX, THE CAUSE OF THE COIL STRETCH WAS NOT DETERMINED. COIL SEPAR ATION/BREAK/PREMATURE DETACHMENT WAS REPORTED FOR THIS COIL, AND IT SPECIFICALLY INVOLVED PREMATURE DETACHMENT. THE COIL PREMATURELY DETACHED WITHIN THE CATHETER, WHICH WAS MODEL NUMBER 105-5091-150, LOT NUMBER 0231044497. FOR COIL APB-2.5-6-3D, THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. FOR THE COILS, THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. NO ISSUES WERE FOUND THAT RESULTED IN THE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803862 ↗
• MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, RUPTURED POSTERIOR COMMUNICATING ARTERY SEGMENT ANEURYSM WITH A MAX DIAMETER OF 5 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE CUSTOMER REPORTED THAT AFTER SELECTING THIS MODEL OF AXIUM COIL, THE COIL WAS AUTOMATICALLY DEPLOYED DURING DELIVERY WITHOUT MECHANICAL DETACHMENT. THE IMPLANT COIL REMAINED IN THE PATIENT, BUT IT IS UNKNOWN WHETHER IT WAS IMPLANTED AT THE INTENDED LOCATION. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED FOLLOWING THE IMPLANTATION. IT WAS UNKNOWN WHETHER THE PUSHWIRE WAS BENT OR BROKEN. IT WAS ALSO UNKNOWN IF THERE WAS FRICTION OR DIFFICULTY DURING DELIVERY, REPOSITIONING OF THE COIL, ATTEMPTS TO DETACH THE COIL, AND ROTATION OF THE DELIVERY PUSHER DURING THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533732 ↗
• MalfunctionAug 21, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT AN AXIUM COIL WAS STRETCHED DURING USE. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL 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 22866601 ↗
• MalfunctionJul 21, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED. NO KINK/DAMAGE WAS OBSERVED ON THE PUSHWIRE. THE COIL DID NOT DETACH FROM THE CATHETER DURING REMOVAL , AND THERE WERE NO ISSUES ENCOUNTERED BEFORE COIL'S NON-DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562410 ↗
• MalfunctionJan 2, 2025Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE COIL STRETCHED. 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 PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED POSTERIOR COMMUNICATING SEGMENT ANEURYSM WITH A MAX DIAMETER OF 3*3MM AND A 2MM 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 21061058 ↗
• MalfunctionOct 24, 2024Stretched; 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 A REPORT THAT WHEN THE SURGEON USED STENT-ASSISTED COIL TO TREAT ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY SEGMENT, HE USED AN APB-1.5-3 COIL TO FINISH. WHEN THE ALTERNATE DETACHMENT METHOD WAS USED FOR DETACHMENT, WHEN THE MICROCATHETER WAS WITHDRAWN, THE SURGEON FELT OBVIOUS RESISTANCE AND FOUND THAT THE COIL BODY MOVED WITH THE PUSH ROD, BUT THE DISTANCE BETWEEN THE MICROCATHETER AND THE COIL WAS ALREADY FAR, AND NO ADHESION OF THE DEVELOPING WIRE WAS FOUND. THE SURGEON SUSPECTED THAT THE COIL WAS STRETCHED AND THE ANTI-STRETCHING WIRE HAD NOT BEEN SEPARATED FROM THE PUSH ROD. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. 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 HAD ATTEMPTED TO DETACH THE COIL. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER (B)(4) TIMES. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE MANUAL METHOD 2 TIMES. NO INSTANT DETACHERS WERE USED. THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING PROCEDU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20527647 ↗
• MalfunctionJan 23, 2024Separation Failure; Detachment of Device or Device Component; Material Deformation; Separation Failure; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE 3 ATTEMPTS AT DETACHMENT. IT WAS NOTED THAT THE PUSHWIRE WAS SLIGHTLY CURVED. THE COIL WAS REMOVED FROM THE PATIENT. THERE WERE 2 COIL IMPLANTED BEFORE THE MALFUNCTION COIL AND ONE IMPLANTED AFTER THE MALFUNCTIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18566306 ↗
• MalfunctionSep 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ON (B)(6) 2023, THE SURGEON PERFORMED ANEURYSM EMBOLIZATION. DURING THE SURGERY, THE COIL COULD NOT PASS THROUGH THE E-10 (STUCK IN THE CATHETER HUB). THE DEVICE WAS STUCK IN THE DISTAL END OF THE CATHETER. NEITHER THE CATHETER NOR THE COIL WERE DAMAGED. THE SURGERY WENT SMOOTHLY AFTER THE COIL WAS REPLACED. 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 M1 ANEURYSM WITH A MAX DIAMETER OF 2.5MM AND A 2.0MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY AND THE CATHETER USED WAS A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744040 ↗
• MalfunctionJul 28, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE APPEARED TO BE NO DAMAGE TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17416863 ↗
• MalfunctionJul 28, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE APPEARED TO BE NO DAMAGE TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17416621 ↗
• MalfunctionOct 18, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM EMBOLIZATION, WHEN THE COIL WAS DELIVERED TO THE MICROCATHETER, THE COIL COULD NOT BE PUSHED IN THE PROTECTIVE SHEATH, IT WAS STUCK AND HAD A LARGE RESISTANCE. THE COIL WAS WITHDRAWN AND REPLACED WITH THE SAME PRODUCT, WHICH WAS SUCCESSFULLY DELIVERED TO THE BODY, AND THE SURGERY WAS COMPLETED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN C6 WITH A MAX DIAMETER OF 3.3MM AND A 2.1MM 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 15629025 ↗
• MalfunctionAug 16, 2022Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL 1/3 OF THE AXIUM PRIME WAS BENT AND KINKED. IN ADDITION, THE COIL WAS STUCK IN THE MICROCATHETER AND COULD NOT BE PUSHED. THE RESISTANCE WAS FOUND AT THE PROXIMAL END OF THE CATHETER. THE COIL DID PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THE CATHETER WAS NOT DAMAGED. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE VFC COIL WAS FILLED AND IT COULD PASS SMOOTHLY AND WAS FILLED. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY WITH A MAX DIAMETER OF 2MM AND A 1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE: 8F GUIDING CATHETER, HEADWAY17 MICROCATHETER, AND A SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15234026 ↗