Axium PrimeTM APB-1.5-3-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536032132), received between Nov 12, 2020 and May 13, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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.

• MalfunctionMay 13, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  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: Foreign Body In Patient

  MAUDE report 14398723 ↗
• MalfunctionMar 21, 2022Stretched; Separation Failure; Physical Resistance/Sticking; Stretched; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE OPERATOR PLACED THE SL 10 MICRO CATHETER WELL INSIDE THE ANEURYSM, THEY HAD TAKEN TARGET 3X8 2X4 DEPLOYED VERY WELL ONE AFTER ONE, THEN LASTLY THEY HAD TAKEN AXIUM HELIX 1.5X3, FLUSH THE SLEEVE OF COIL AS PER IFU PLACED COIL INSIDE INTO ANEURYSM WITH SLOWLY FORWARD PUSHING. BUT WHEN OPERATOR WANTS TO DETACH IT, IT COULDN'T DETACH WITH ID EVEN MANUAL DETACHMENT, TRIED 3-4 ATTEMPTS BUT NO USE. WHILE PULLING BACK THE COIL INSIDE INTO SL 10, OPERATOR NOTICED COMPLETE COIL COULDN'T CAME INSIDE IN TO MICRO. THERE WAS FRICTION. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THEY STOPPED PULLING THE COIL REMOVED ENTIRE MICRO FROM THE ANEURYSM. THEY NOTICED COIL GOT STRETCHED INSIDE THE MICRO. THEY THEN USED A NEW SL 10 FINISH THE CASE WITH PUTTING TARGET 1X3 COIL. 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 FOR ACOM ANEURYSM COILING OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 3.87MM AND A 2.9MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13844522 ↗
• MalfunctionJul 22, 2021Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE PACKAGING WAS INTACT WITHOUT EVIDENCE OF TAMPERING OR DAMAGE. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211465 ↗
• MalfunctionJul 5, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT OF AN UNRUPTURED, SACCULAR ICA PARACLINOID ANEURYSM WITH A MAX DIAMETER OF 4MM AND A NECK WIDTH OF 2MM. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW SPEED AND VESSEL TORTUOSITY WERE UNKNOWN. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A 6F SOFIA GUIDE CATHETER, SL-10 MICROCATHETER, SYNCHRO GUIDEWIRE. ADDITIONAL INFORMATION RECEIVED NOTED THAT OVER 5 DETACHMENT ATTEMPTS WERE MADE WITH AN INSTANT DETACHER, AND SEVERAL DETACHMENT ATTEMPTS WITH THE MANUAL DETACHMENT METHOD. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT. NO DAMAGE TO THE PUSHWIRE WAS SEEN UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116439 ↗
• MalfunctionApr 26, 2021Separation Failure; Migration; Separation Failure; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN INSTANT DETACHER WAS NOT USED. ONE ATTEMPT WAS MADE TO DETACH THE COIL USING THE MANUAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726757 ↗
• MalfunctionFeb 8, 2021Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11297572 ↗
• MalfunctionNov 12, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS NO KINK OR DAMAGE OBSERVED TO THE PUSHWIRE.

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

  MAUDE report 10833416 ↗