Axium PrimeTM APB-1.5-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00847536032125), received between May 15, 2020 and Mar 16, 2023 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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.

• MalfunctionMar 16, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A 1.5-2-HX AXIUM COIL WAS NOT INSERTED AT THE MICROCATHETER HUB. SO, AS A RESULT IT WAS REMOVED AND THE COIL WAS CHECKED, IT TURNED OUT TO BE A COIL PRE-DETACHED. THE PROCEDURE WAS COMPLETED BY REPLACING IT WITH AN SAME SIZE AXIUM COIL. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN CATHETER HUB. IT IS UNKNOWN IF THE COIL WAS PUSHED SMOOTHLY OUT OF THE INTRODUCER SHEATH. THERE WAS NO CATHETER DAMAGE OR COIL DAMAGE OBSERVED. 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 16551972 ↗
• MalfunctionSep 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED NO DETACHMENT ATTEMPTS WERE MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE COIL WAS IMPLANTED. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THE PHYSICIAN PUSHED THE PRE DETACHED COIL WITH THE WIRE. ONLY THE PUSHWIRE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459336 ↗
• MalfunctionMay 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 3MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE COIL AUTOMATICALLY DETACHED, AND WAS REMOVED WITH A THROMBECTOMY STENT. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY, AND THE PHYSICIAN DID NOT REPOSITION THE COIL. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A SOLITAIRE AB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408277 ↗
• MalfunctionMay 13, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING 2 AXIUM COILS USED IN A PROCEDURE, ONE OF WHICH WAS STRETCHED AND DETACHED PREMATURELY AND ANOTHER THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 4MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. ONE COIL DETACHED PREMATURELY AND WAS STRETCHED; THE COIL WAS REMOVED WITH A SOLITAIRE AB (SAB) STENT RETRIEVER. THERE WAS BEEN NO FRICTION OR OTHER DIFFICULTY NOTED DURING DELIVERY. THE PHYSICIAN DID NOT ATTEMPT TO REPOSITION OR DETACH THE COIL. ANOTHER COIL USED IN THE PROCEDURE COULD NOT BE DETACHED. 5 ATTEMPTS WERE MADE TO MANUALLY DETACH THE COIL WITHOUT SUCCESS. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398837 ↗
• MalfunctionFeb 3, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE MAX DIAMETER WAS 2MM, AND THE NECK DIAMETER WAS 1MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESISTANCE WAS IN THE MIDDLE OF THE ECHELON 10 MICROCATHETER. THE COIL HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447090 ↗
• MalfunctionOct 11, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS NO VISIBLE KINK OR DAMAGE TO THE PUSHWIRE. THERE WAS NO RESISTANCE DURING DELIVERY OR RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12606725 ↗
• MalfunctionAug 25, 2021Incomplete or Missing Packaging; Material Deformation; Incomplete or Missing Packaging; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT WITH TWO COILS "THERE WASN'T COIL BODY ," AND TWO COILS COULDN'T BE PUSHED OUT OF THE PROTECTIVE SHEATH. THE COILS WERE REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, AMORPHOUS ANEURYSM LOCATED IN THE OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 4.21MM, AND THE NECK DIAMETER WAS 3.11MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE STATEMENT "THERE WASN'T COIL BODY" MEANT THAT THERE WERE NO COILS ON THE PUSHER ROD DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367877 ↗
• MalfunctionAug 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO DETACHMENT ATTEMPTS MADE, AND NO KINK/DAMAGE WAS OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360500 ↗
• MalfunctionJul 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO KINK/DAMAGE OBSERVED TO THE PUSHWIRE. ANCILLARY DEVICES INCLUDE AN ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12247800 ↗
• InjuryJul 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3.8MM, AND THE NECK DIAMETER WAS 1.9MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE SECOND COIL USED ACCIDENTALLY DETACHED AND HERNIATED INTO THE TUMOR-CARRYING ARTERY. A STENT WAS USED TO ATTACH THE COIL TO THE WALL. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION. THE PUSHWIRE WAS NOT BENT OR BROKEN, AND THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY. NO DETACHMENT ATTEMPTS HAD BEEN MADE. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: Foreign Body In Patient

  MAUDE report 12125122 ↗
• MalfunctionDec 16, 2020Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT AFTER OPENING THE PACKAGE, IT WAS FOUND THE AXIUM COIL PUSHWIRE WAS BROKEN AND COULD NOT BE USED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND 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 ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 3 MM AND A 2.5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO THE DEVICE PACKAGING. THE THE PACKAGE WAS OPENED, THE PROXIMAL END OF THE PUSHWIRE WAS NOT SECURE IN THE GUIDEWIRE CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023897 ↗
• MalfunctionSep 29, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE SL-10 MICROCATHETER. WHEN THE COIL WAS REMOVED, IT WAS FOUND THAT THE COIL WAS STRETCHED. IT WAS NOTED A CONTINUOUS FLUSH HAD BEEN USED, AND A REPLACEMENT COIL WAS USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE. THE PATIENT WAS TREATED FOR AN UNRUPTURED BIFURCATION ANEURYSM OF THE MIDDLE CEREBRAL ARTERY. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2.2MM. PATIENT VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10602663 ↗
• MalfunctionMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. IT WAS REPORTED THAT THE AXIUM COIL BECAME DETACHED WHILE ADVANCING THROUGH A NON-MEDTRONIC CATHETER. THE SURGEON DECIDED TO CONTINUE AND PUSHED THE DETACHED COIL THROUGH THE CATHETER WITH A MICROWIRE AND THE COIL WAS IMPLANTED IN THE PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10062416 ↗