Axium PrimeTM APB-2-8-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536032200), received between Apr 1, 2020 and Aug 17, 2022 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2022Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT ANEURYSM EMBOLIZATION WAS PERFORMED. MICROCATHETER SHAPING FOUND THE TIP WAS BROKEN. THERE WAS CATHETER RUPTURE (INTACT). THE RUPTURE WAS IN THE DISTAL END, THERE WAS NO FRICTION, THERE WAS NO OTHER DAMAGE TO THE CATHETER. AFTER THE MICROCATHETER WAS IN PLACE SUCCESSFULLY, SELECTED APB-2-8-HX-ES FOR FILLING AFTER FORMING A HOOP WAS COMPLETED. THE COIL WAS STRETCHED. 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 AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR INTRACRANIAL ANEURYSM TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM AND A 5MM NECK DIAMETER. ACCESS VESSEL WAS THE FEMORAL ARTERY WITH 8MM DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A JOHNSON <(>&<)> JOHNSON 6F ENVOY 100 GUIDE CATHETER AND ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240249 ↗
• MalfunctionMay 19, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED AFTER BEING IMPLANTED. AFTER SEVERAL ATTEMPTS, IT DID NOT WORK AND THE COIL WAS REMOVED. THE PHYSICIAN DID NOT USE A DETACHMENT DEVICE, BUT RATHER USED THE HAND-BREAKING METHOD DIRECTLY VIA HYPOTUBE. THIS WAS ATTEMPTED TWICE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID OPHTHALMIC ARTERY SEGMENT WITH A MAX DIAMETER OF 4.2MM AND A 3.01MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE: COOK 6F SHEATH, NAVIEN 105 6F GUIDE CATHETER, EV3 ECHELON10 MICROCATHETER, AND SYNCHRO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436121 ↗
• MalfunctionMar 29, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF A BASILAR ARTERY. THE ANEURYSM MAX DIAMETER WAS 4MM AND THE NECK DIAMETER WAS 3MM. 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). DURING D ELIVERY, THE COIL COULD NOT BE PUSHED IN THE MICROCATHETER AND WAS REMOVED FOR SAFETY. IT WAS THEN FOUND THAT THE COIL WAS STUCK IN THE PROTECTIVE SHEATH. THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ON 2021-08-18 (REP, FOR): ADDITIONAL INFORMATION RECEIVED INDICATED 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 13938419 ↗
• MalfunctionDec 14, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE USER DOES NOT USE THE INSTANT DETACHER. IN THE PROFESSOR'S OPINION, THE AGE, WEIGHT OF THE PATIENT AND ANATOMY, OR THE MICROCATHETER USED (WHICH WAS THE CORRECT DIAMETER), ETC., HAD NO BEARING ON THE VERDICT REGARDING THE EQUIPMENT. AT THE SAME TIME, HE ENSURES THAT THE PATIENT HAS LEFT WITHOUT A CUPBOARD AND FEELS GOOD. PROFESSOR IS CONVINCED OF THE DEFECTIVENESS OF THIS PARTICULAR PIECE OF COIL. PROFESSOR BELIEVES THAT THE COIL HAS NOT RELEASED (DIDN¿T DETACH) AFTER TRYING TO MANUALLY UNHOOK (WITHOUT ID-1-5). ON THE OTHER HAND, OTHER EXTERNAL FACTORS HAVE NO INFLUENCE ON THE ISSUE OF COIL NOT DETACHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004315 ↗
• MalfunctionAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS AUTOMATICALLY DETACHED WHEN ADJUSTING THE COIL. A STENT WAS USED TO REMOVE THE COIL FROM THE PATIENT SUCCESSFULLY: NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. IT WAS UNKNOWN IF THERE WAS ANY DAMAGE TO THE PUSHWIRE, AND UNKNOWN IF THERE WAS ANY FRICTION. REPOSITIONING WAS PERFORMED THREE TIMES, NO DETACHMENT ATTEMPTS WERE MADE, NO ROTATION WAS PERFORMED, AND A CONTINUOUS FLUSH WAS USED. A REPLACEMENT PRODUCT 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY WITH A MAX DIAMETER OF 8 MM AND A 5 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS UNKNOWN AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285933 ↗
• MalfunctionNov 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE AXIUM COIL WAS PREPARED PER THE INSTRUCTIONS FOR USE. PRIOR TO COIL IMPLANTATION, MICROSPHERES HAD BEEN IMPLANTED. WHEN THE AXIUM COIL DETACHED PREMATURELY, THE COILING PORTION OF THE PROCEDURE WAS ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906398 ↗
• MalfunctionMay 12, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTING THAT THE AFTER THE COIL WAS REMOVED, IT WAS DETACHED BY MANUAL METHOD. THERE WAS NO DAMAGE TO THE PUSHWIRE. THE SURGERY WAS COMPLETED WITH ANOTHER MEDTRONIC COIL OF A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE FOR ANEURYSM EMBOLIZATION. THE PATIENT HAD BEEN TREATED FOR AN ANEURYSM OF THE LEFT INTERNAL CERVICAL CLINOID SEGMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10047569 ↗
• MalfunctionApr 1, 2020Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM DETACHMENT MARKER/PUSHWIRE HAD BROKEN OFF IN THE ECHELON 10 MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A NEUROVASCULAR ABNORMALITIES. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE INTRODUCTION OF THE THIRTEENTH COIL, THE DOCTOR NOTICED THE DETACHMENT MARKER FROM THE PREVIOUS COIL WAS VISIBLE IN THE INTERNAL CAROTID ARTERY: THE PUSHWIRE HAD BROKEN OFF IN THE DISTAL SEGMENT. THERE WAS NO FRICTION OR DIFFICULTY NOTED DURING DELIVERY, AND EVERYTHING FELT NORMAL. THE MARKER/PUSHWIRE WAS RETRIEVED BY REMOVING THE COILING CATHETER. THE DISTAL PORTION OF THE DEVICE WOULD BE RETURNED FOR ANALYSIS, BUT THE PROXIMAL SEGMENT WAS DISCARDED. THERE WAS NO PATIENT HARM, AND THE PROCEDURE CONTINUED AS NORMAL. ANCILLARY DEVICES INCLUDE A BENCHMARK 6F AND ECHELON 10.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9910663 ↗