Axium Prime Detachable Coil System APB-1.5-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000313821), received between Apr 11, 2023 and Mar 9, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Break; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE DETACHMENT OF THE AXIUM PRIME BARE HX COIL OCCURRED AUTOMATICALLY WITHOUT ACTIVATION OF THE PUSHER ROD. IT WAS NEAR THE ANEURYSM. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION, HOWEVER, THE OPERATOR OBSERVED THAT THERE WAS MINIMAL IMPACT ON BLOOD FLOW AND DECIDED NOT TO RETRIEVE THE COIL. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, FUSIFORM, MIDDLE CEREBRAL ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PUSHWIRE WAS INTENTIONALLY BENT OR BROKEN. IT IS UNKNOWN IF THE PHYSICIAN REPOSITIONED THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL, HOWEVER, THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING PROCEDURE. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO ISSUE WITH AN INSTANT DETACHER; CO

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544997 ↗
• MalfunctionJan 15, 2026Stretched

  MEDTRONIC RECEIVED A REPORT THAT DURING ANEURYSM EMBOLIZATION, WIRE DRAWING (STRETCH) OF THE COIL BODY WAS OBSERVED WHILE DELIVERING THE COIL. THE COIL WAS PROMPTLY REMOVED AND REPLACED WITH A MEDTRONIC PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED, AMORPHOUS, RIGHT ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.3 MM AND A 1.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY, THE COIL WAS NOT REPOSITIONED, AND CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE. THE DAMAGED/STRETCHED LOCATION WAS ON THE IMPLANT COIL. ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES THAT RESULTED IN THE COIL DAMAGE. THE CAUSE OF THE COIL STRETCH WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086302 ↗
• MalfunctionDec 23, 2025Break; Detachment of Device or Device Component; Packaging Problem; Break; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PREMATURE DETACHMENT. NO DAMAGE WAS NOTICED UPON OPENING THE PACKAGE, AND NO EVIDENCE OF TAMPERING OR DAMAGE TO THE DEVICE PACKAGING WAS OBSERVED, INCLUDING ON DELIVERY. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. THE DAMAGE WAS SEEN AFTER PULLING OUT THE COIL, BUT NO KINK OR DAMAGE WAS OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885449 ↗
• MalfunctionNov 17, 2025Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT AN AXIUM COIL COULD NOT BE DETACHED. NO PATIENT INFORMATION OR OTHER EVEN DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569776 ↗
• MalfunctionSep 12, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT HARMED AND THE OPERATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199602 ↗
• MalfunctionJun 27, 2024Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE¿PUSHWIRE¿WAS SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE¿PACKAGE WAS¿OPENED. THE BREAK WAS LOCATED 10MM FROM THE TAIL END OF THE PUSHER ROD. THERE WAS SELF-DAMAGE, ELIMINATING PROBLEMS WITH UNPACKING AND OPERATION ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624903 ↗
• MalfunctionMar 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL ENCOUNTERED RESISTANCE IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 4.56 MM AND A 1.9 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. THE PATIENTS PAST MEDICAL HISTORY INCLUDES HYPERTENSION. IT WAS REPORTED THAT THE AXIUM COIL COULDN'T PUSH OUT THE PROTECTIVE SHEATH. IT WAS REPORTED THERE WAS COIL RESISTANCE/STUCK IN SHEATH. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DURING PREPARATION, 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 18921377 ↗
• MalfunctionDec 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM SPRING COILS COULD NOT BE PUSHED OUT OF THE INTRODUCTION SHEATH. TWO OTHER AXIUM COILS COULD NOT BE DELIVERED SMOOTHLY IN THE CATHETER AFTER BEING PUSHED OUT OF THE INTRODUCTION SHEATH. THE AXIUM COILS WERE STUCK AT THE PROXIMAL END OF THE CATHETER. THE AXIUM COILS AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A AMORPHOUS, UNRUPTURED ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM WITH A MAX DIAMETER OF 9.2MM AND A 4.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CATHETER WAS A MEDTRONIC PRODUCT. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. IT WAS ALSO REPORTED THAT THE ON-SITE CONTACT PERSON MADE A MISTAKE IN THE INITIAL COMMUNICATION. IN FACT, THE APB-1-2-HX-ES (LOT NUMBER 225549305) IN THE REPORT DID NOT REQUIRE A COMPLAINT OR PICKUP. THE SURGEON REPORTED THAT THE 1-2 COIL WAS DIFFICULT TO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332362 ↗
• MalfunctionJul 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS DETACHED PREMATURELY IN THE MICROCATHETER. THE COIL WAS NOT YET IMPLANTED IN THE PATIENT. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. IT WAS UNKNOWN IF THE PUSHWIRE WAS BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. CONTINUOUS LUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. 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 OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 3MM AND A 1.3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE AN ECHELON10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374845 ↗
• MalfunctionApr 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS BROKEN.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C5 SEGMENT OF THE INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.26MM AND A 2.46MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THE SPRING COIL WAS FOUND TO BE BROKEN DURING THE HYDRATION PROCESS. IT WAS NOTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL WAS NOT IMPLANTED. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL AND DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE AN ECHELON MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712564 ↗