Axium PrimeTM 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 00847536032149), received between Sep 10, 2020 and Dec 4, 2023 — classified as 1 injury, 7 malfunctions.

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

• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE LOCATION IN THE CATHETER OF THE RESISTANCE WAS UNKNOWN. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED ON THE COIL AFTER REMOVAL. THERE WERE NO ISSUES THAT RESULTED FROM THE DAMAGE THAT WAS FOUND. THERE WERE NO DETACHMENT ATTEMPTS. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE PHYSICIAN OBSERVED THE PREMATURE DETACHMENT IN THE CATHETER. IT WAS UNKNOWN HOW MANY COILS WERE IMPLANTED BEFORE AND AFTER THE MALFUNCTIONED COIL. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED DUE TO COIL IMPLANTATION IN AN UNTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257582 ↗
• MalfunctionDec 13, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE SPRING COIL WAS BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE RIGHT INTERNAL CAROTID ARTERY AND THE POSTERIOR COMMUNICATING ARTERY SEGMENT WITH A MAX DIAMETER OF 3.7MM AND A 2.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE PROCESS OF FILLING THE ANEURYSM WITH THE SPRING COIL, WHEN THE SURGEON WAS ADJUSTING THE POSITION OF THE SPRING COIL, IT WAS FOUND THAT THE MIDDLE PART OF THE SPRING COIL WAS BROKEN UNDER ANGIOGRAPHY. 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. 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 15965817 ↗
• MalfunctionMar 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THREE COILS WERE SUCCESSFULLY DEPLOYED. THE COMPLAINT COIL WAS THE FOURTH TO BE USED. AFTER THE COIL WAS PUSHED OUT OF THE SHEATH, IT DETACHED PREMATURELY IN THE MICROCATHETER. THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL. THE PUSHWIRE WAS NOT DAMAGED. THE COIL WAS REMOVED WITH THE MICROCATHETER AND WAS REPLACED TO CONTINUE THE PROCEDURE. NO ADDITIONAL SURGICAL AND MEDICINAL INTERVENTION WAS REQUIRED. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: ECHELON 10 MICROCATHETER, SYNCHRO 14 GUIDEWIRE 2022-03-09 ARED (FOR, REP, HCP): N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13844855 ↗
• InjuryFeb 28, 2022Break; Stretched; Detachment of Device or Device Component; Break; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STRETCHED BY PUSHING IT ONCE DURING THE SURGERY AND FINALLY THE COIL COULD ONLY BE REMOVED. WHEN THE MICROCATHETER WAS WITHDRAWN, THE STRETCHED COIL FELL INTO THE LEFT RENAL ARTERY. THE COIL SEPARATED/BROKE/PREMATURELY DETACHED IN THE PATIENT'S RENAL ARTERY AND REMAINED IN THE PATIENT. THE COIL WAS NOT IMPLANTED AT IT'S INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS FRICTION/DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND THEY DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. A CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A AMORPHOUS, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX D IAMETER OF 5.8MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 13621255 ↗
• MalfunctionJan 24, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT COULD NOT BE DETACHED AND ANOTHER AXIUM COIL THAT HAD RESISTANCE AND JUMPING DURING DELIVERY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED AMORPHOUS CAVERNOUS SINUS SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5.37MM AND THE NECK DIAMETER WAS 4.27MM. BLOOD FLOW WAS HIGH. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE AXIUM COIL (MODEL: APB-1.5-4-HX-ES, LOT: B170548) COULD NOT BE DETACHED DURING THE FILLING PROCESS. 2 ATTEMPTS WERE MADE WITH ONE INSTANT DETACHER (ID) AND 1 ATTEMPT WAS MADE WITH A SECOND ID WITHOUT SUCCESS; IT WAS NOTED THERE WAS NO ISSUE WITH THE INSTANT DETACHERS. 1 ATTEMPT WAS ALSO MADE AT MANUAL DETACHMENT WITHOUT SUCCESS. THE COIL WAS REMOVED AND REPLACED.  DURING THE SAME PROCEDURE, ANOTHER AXIUM COIL (MODEL: QC-4-8-3D, LOT: B201128) FELT VERY HARD DURING THE FILLING PROCESS WITH JUMPING OBSERVED AND THE COIL COULD NOT BE RANDOMLY TURNED IN THE ANEURYSM. IT WAS NOTED THE TIP OF THE CATHETER WAS MOVED DURING DEPLOYMENT. THE PHYSICIAN ROTATED THE PUSHER. THERE WAS CONCERN THAT THE COIL C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333584 ↗
• MalfunctionJul 30, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  THE COIL WAS DETACHED IN THE MICROCATHETER. THE CATHETER WAS ECHELON10, LOT# UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12254859 ↗
• MalfunctionJul 6, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DID NOT DETACH DURING ATTEMPTS INTRA-OPERATIVELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW WAS LOW. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE AXIUM COIL WAS DELIVERED TO THE ANEURYSM LOCATION AND THE DETACHMENT WIRE WAS BROKEN BUT THE SPRING RING COULD NOT BE DETACHED. THE COIL WAS SLOWLY WITHDRAWN FROM THE PATIENT'S BODY AS A WHOLE. DURING OBSERVATION, THE COIL WAS DETACHED. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12121883 ↗
• MalfunctionSep 10, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10514923 ↗