Axium PrimeTM APB-1-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536032095), received between Apr 23, 2020 and Mar 14, 2024 — classified as 7 malfunctions.

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

• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT ONE OF THE COIL FAILED TO PASS THE MICROCATHETER'S HUB. THE SECOND COIL WAS STRETCHED IN THE MICROCATHETER. THE THIRD COIL'S WIRE WAS BROKEN WHEN THE DOCTOR TOOK IT OUT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO SYMPTOMS ASSOCIATED WITH THIS EVENT. THE MODEL NUMBER OF THE COIL THAT FAILED TO PASS THE MICROCATHETER HUB (LOT NUMBER A239068) B239068. THE COIL DID NOT COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT; STRYKER SL-10.THE COIL¿S WIRE WAS BROKEN INSIDE THE BOX. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS PREPARATION COMPLETED BEFORE THE DAMAGE WAS NOTICED AND THAT THE DAMAGE WAS NOTICED IMMEDIATELY AFTER OPENING THE PACKAGE. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. 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 18900132 ↗
• MalfunctionDec 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT VESSEL TORTUOSITY WAS NORMAL. THE PATIENT DIDN'T EXPERIENCE ANY SYMPTOMS RELATED TO THE PREMATURE DETACHMENT. THE CAUSE OF THE PUSHER KINK WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. NO DETACHMENT ATTEMPTS WERE ATTEMPTED. IT WAS NOTED THAT THE DOCTOR USED 5 OR 6 COILS IN TOTAL. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18257570 ↗
• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE DISTAL PART OF THE ECHELON 10 MICROCATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4 MM. THE NECK DIAMETER WAS 3 MM. THE PATIENT¿S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, AND IT WAS 7 MM IN DIAMETER. IT WAS REPORTED THAT THE SPRING COIL COULD NOT BE PUSHED OUT OF THE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE AXIUM COIL PUSH OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430056 ↗
• MalfunctionMay 20, 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 A RUPTURED SACCULAR LEFT INTERNAL CAROTID ARTERY (ICA) C4 SEGMENT ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 3.5MM. 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 WITH THE MICROCATHETER. AFTER FILLING ABOUT 1CM, THE PHYSICIAN WANTED TO MAKE AN ADJUSTMENT. WHEN THE PUSHER WAS PULLED BACK, THERE WAS NO RESISTANCE AND THE COIL DID NOT FOLLOW THE MOVEMENT. IMAGING CONFIRMED THAT THE PUSHER WAS WITHDRAWN ABOUT 10CM AND THE DETACHMENT POINT OF THE COIL DID NOT CHANGE INDICATING THAT THE PROXIMAL END OF THE COIL WAS DETACHED FROM THE PUSHER IN THE MICROCATHETER. THEREFORE, THE PUSHER WAS USED TO PUSH THE COIL INTO THE ANEURYSM AND THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. IT WAS NOTED THAT THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. THE PUSHER WAS NOT BENT OR BROKEN. ONLY ONE ATTEMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14454318 ↗
• MalfunctionSep 3, 2020Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS STRETCHED AND BECAME STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE RIGHT MIDDLE ARTERY WITH A MAX DIAMETER OF 1.5MM AND A 1MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT AFTER HYDRATION, EMBOLIZATION WAS PERFORMED WITH THE ECHELON-10 MICROCATHETER. THE SURGEON DESCRIBED THE COIL AS BEING FELT HARD AND ABNORMAL DURING THE SURGERY. DURING THE SECOND DELIVERY ATTEMPT, THE COIL WAS NOT PUSHED OUT OF THE SHEATH WHEN PUSHING IT INTO THE MICROCATHETER. ONCE REMOVED, IT WAS FOUND STRETCHED. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED, AND THE PHYSICIAN REPOSITIONED THE COIL THREE TIMES. FOLLOW-UP RESPONSE RECEIVED REPORTING THAT THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE AS IT WAS HYDRATED DURING PREPARATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10488616 ↗
• MalfunctionMay 7, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WOULD NOT DETACH, AND THEN PREMATURELY DETACHED UPON REMOVAL. IT WAS REPORTED THAT THE SPRING COIL COULDN¿T BE DETACHED WHEN IMPLANTED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL TWICE MANUALLY. DURING THE PROCESS OF PUSHING IT OUT OF THE BODY, IT AUTOMATICALLY DETACHED. THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER MEDTRONIC COIL. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT FOR A UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT MIDDLE CEREBRAL ARTERY BRANCH BETWEEN M1 AND M2. THE MAX DIAMETER WAS 4.58 MM. THE NECK DIAMETER WAS 3.97 MM. THE PATIENT¿S BLOOD FLOW AND TORTUOSITY WERE NORMAL. THE PATIENT¿S MEDICAL HISTORY INCLUDED SMOKING AND HYPERTENSION FOR MORE THAN 10 YEARS. ANCILLARY DEVICES INCLUDE A NAVIEN GUIDE CATHETER AND AN ECHELON MICROCATHETE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10037161 ↗
• MalfunctionApr 23, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH DURING A PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN UNRUPTURE SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 8MM WITH A NECK DIAMETER OF 4MM. THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS DESCRIBED IN THE MANUFACTURER INSTRUCTIONS FOR USE. THE SURGEON ATTEMPTED TO DETACH THE COIL TWICE WITH THE INSTANT DETACHER AND TWICE MANUALLY WITHOUT SUCCESS. THE COIL WAS REMOVED AND COMPETITOR'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9991571 ↗