Axium PrimeTM APB-1.5-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536031845), received between Dec 6, 2019 and Jul 27, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE A COIL PREMATURELY DETACHED IN THE MIDDLE OF THE CATHETER DURING DEPLOYMENT, AND ANOTHER COIL BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ICA. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PUSHWIRE WAS NOT BENT OR BROKEN, AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY WITH THE COIL THAT PREMATURELY DETACHED. THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS WERE MADE, AND THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THERE WAS NO DAMAGE TO THE CATHETER OR THE COIL THAT WAS STUCK IN THE MICROCATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118119 ↗
• MalfunctionMar 9, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT AFTER 2 COILS WERE SUCCESSFULLY DELIVERED. WHILE FILLING THE THIRD COIL, THE COIL WAS NOT WELL DEVELOPED WHEN DELIVERED. AFTER IT WAS PUSHED OUT, IT WAS OBSERVED THAT THERE WAS NOT COIL AT THE TIP END. THE COIL WAS REPLACED WITH ANOTHER OF THE SAME MODEL WHICH WAS USED SUCCESSFULLY AND A FOURTH COIL WAS DELIVERED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).  THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 2.8MM AND THE NECK DIAMETER WAS 4.2MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE PATIENT CONDITION WAS STABLE. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS "NOT DAMAGED, NOT SEPARATED, AND WITHOUT SPRING COILS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13716678 ↗
• MalfunctionSep 8, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN INSTANT DETACHER WAS NOT USED IN THE PROCEDURE, AND THE MANUAL DETACHMENT METHOD TO BREAK THE DETACHMENT ZONE WAS USED INSTEAD. THE DELIVERY PROCESS WAS NORMAL AND THE FILLING PROCESS WAS ALSO SMOOTH WITHOUT ANY PROBLEMS. THERE WAS NO DAMAGE TO THE PUSHWIRE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12440772 ↗
• MalfunctionSep 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER THE COIL DETACHED AND WAS IMPLANTED IN THE ANEURYSM, A STENT WAS IMPLANTED TO HOLD THE COIL IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438879 ↗
• MalfunctionJun 29, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL DID NOT PASS THE MICROCATHETER SHEATH. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICE: SL-10 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089416 ↗
• MalfunctionFeb 5, 2021Break; Stretched; Separation Failure; Break; Stretched; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH AND BECAME STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3.8MM AND THE NECK DIAMETER WAS 2.5MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS IN PLACE FOR ANEURYSM FILLING. THE AXIUM COIL (MODEL: APB-1.5-2-3D-ES) WAS CHOSEN AND, WHEN DEPLOYED, COULD NOT BE DETACHED. AFTER REPEATED ATTEMPTS, THE TAIL WAS STRETCHED. SOME OF THE COIL REMAINED IN THE ANEURYSM. THE COIL WAS REMOVED, REPLACED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED INDICATED TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND ANOTHER TWO ATTEMPTS WITH THE MANUAL METHOD. THERE WERE NO ISSUES REPORTED PRIOR TO NON-DETACHMENT OF THE COIL, NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL, AND IT WAS STATED THERE WAS NO PROBLEM WITH THE DETACHMENT DEVICE AS IT WAS USED TO DETACH OTHER COILS WITHOUT ISSUE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11286380 ↗
• MalfunctionDec 6, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH. THE INSTANT DETACHER WAS USED 3 TIMES AND 2 MANUAL DETACHMENT ATTEMPTS WERE MADE BUT FAILED. A NEW COIL OF THE SAME SIZE WAS USED, AND THE COIL WAS DETACHED WITH THE INSTANT DETACHER. A SECOND DETACHER WAS NOT USED. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF AN ACOM, UNRUPTURED ANEURYSM, THAT WAS SACCULAR. THE MAX DIAMETER WAS 4MM AND THE NECK D IAMETER WAS 2MM. THE BLOOD FLOW AND THE ANATOMY WERE BOTH NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9432633 ↗