Axium PrimeTM APB-1-2-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536031814), received between Jan 25, 2021 and Feb 13, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (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.

• MalfunctionFeb 13, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL FAILED TO DETACH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED ANEURYSM OF THE RIGHT M2. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16362382 ↗
• MalfunctionOct 25, 2022Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT PRIOR TO COIL NON-DETACHMENT, THERE WAS NO ISSUE. THEY REMOVED COIL FROM MICRO CATHETER AND USED ANOTHER AXIUM COIL. THERE WAS NO PUSHWIRE¿DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667701 ↗
• MalfunctionMar 2, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS BEING TREATED FOR A RUPTURED FUSIFORM ANEURYSM IN THE MIDDLE CAROTID ARTERY (MCA). THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 4MM. PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  A COIL FORM ANOTHER COMPANY WAS DEPLOYED. THEN A SECOND COIL WHICH WAS FROM MEDTRONIC WAS PREMATURELY DETACHED. SOME COIL PART CAME IN TO THE PARENT ARTERY. PHYSICIAN THEN CHOSE TO DEPLOY AN ATLAS STENT. THE COIL REMAINS IN PATIENT. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. NO SURGICAL OR MEDICAL INTERVENTION IS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN REPOSITIONED THE COIL 2 TIMES. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. THEY TRIED 2 TIMES WITH THE INSTANT DETACHER. THEY TRIED 1 TIME USING THE MANUAL METHOD. 1 INSTANT DETACHER WAS USED. THE PHYSICIAN DIDN'T NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT IS FINE. NO SYMPTOMS WERE REPORTED.  ANCILLARY DEVICES: NEURON GUIDE CATHETER, SL 10 MICROCATHETER, SYNCHRO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656388 ↗
• MalfunctionJan 21, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR INTERNAL CAROTID ARTERY OPHTHALMIC ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 2MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS DELIVERED BUT COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TWICE TO DETACH THE COIL WITH THE INSTANT DETACHER (ID) WITHOUT SUCCESS. NO ATTEMPT WAS MADE TO DETACH THE COIL MANUALLY. NO ISSUE WAS NOTED WITH THE INSTANT DETACHER. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13315029 ↗
• InjuryDec 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL WHEN IT DETACHED PREMATURELY. THERE WAS NO KINK OR OTHER DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13011749 ↗
• MalfunctionOct 22, 2021Break; Material Deformation; Break; Material Deformation

  ADDITIONAL INFORMATION RECEIVED CLARIFICATION THAT THE PUSHER KINKED AT THE PROXIMAL END, NOT SEPARATED. THERE WERE NO ISSUES NOTED DURING THE PROCEDURE THAT CONTRIBUTED TO THE DAMAGE. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS WILL BE SUBMITTED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682216 ↗
• MalfunctionApr 9, 2021Detachment 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 ANEURYSM OF THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 3.5MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL BECAME DETACHED WITHIN THE MICROCATHETER. NO FRICTION OR OTHER DIFFICULTY HAD BEEN OBSERVED DURING DELIVERY OF THE COIL. THERE WAS NO DAMAGE TO THE COIL PUSHWIRE. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE PUSHWIRE. NO ATTEMPT HAD BEEN MADE TO DETACH THE COIL. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE MICROCATHETER WAS REMOVED WITH THE COIL WITHIN AND 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 11641014 ↗
• MalfunctionJan 25, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ISSUES REPORTED THAT MAY HAVE RESULTED IN THE DAMAGE FOUND TO THE COIL. TWO DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER AND TWO ATTEMPTS VIA THE MANUAL DETACHMENT METHOD. AFTER REMOVAL, THERE WAS NO DAMAGE REPORTEDLY OBSERVED TO THE PUSHWIRE. THE INSTANT DETACHER LOT #: A873975; MICROCATHETER MODEL: 145-5091-150; LOT #: B083780.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222409 ↗