AxiumTM APB-3.5-10-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536021273), received between Jul 5, 2018 and Aug 26, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN IF THERE WERE ANY ISSUES THAT RESULTED IN THE EXTENSION/UNRAVELING THAT WAS EXPERIENCED. THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS DAMAGE IN THE PROXIMAL AREA OF THE COIL. THERE WAS NO KINK/DAMAGE TO THE CATHETER. THE CAUSE OF THE RESISTANCE WAS SAID TO BE THE DAMAGE TO THE PROXIMAL AREA OF THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900256 ↗
• MalfunctionJan 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS STUCK IN THE MICROCATHETER DURING INSERTION. THE COIL DID NOT COME OUT OF THE MICROCATHETER TIP. THE MICROCATHETER WAS REMOVED, AND A NEW COIL AND CATHETER WERE USED. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE A1 SEGMENT OF THE RIGHT ANTERIOR CEREBRAL ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2.8MM. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ANCILLARY DEVICES INCLUDE A HEADWAY 17 MICROCATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085436 ↗
• MalfunctionOct 24, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A COIL WAS INSERTED AND DETACHMENT WAS ATTEMPTED, BUT IT COULD NOT BE DETACHED. THERE WAS DETACHMENT FAILURE. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. 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 PACKAGE INSERT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM WITH A MAX DIAMETER OF 5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20525452 ↗
• MalfunctionSep 10, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL WAS NOT IMPLANTED AS IT WAS IMPOSSIBLE TO PUSH THE COIL THROUGH THE MICROCATHETER HUB. THIS WAS THE FIRST COIL USED. THE MICROCATHETER WAS SWITCHED TO AN ECHELON AND THE SAME PROBLEM OCCURRED. AFTER THAT, A VASCO+10 MP FROM BALT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10516298 ↗
• MalfunctionJan 17, 2020Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THIS COIL WOULD NOT ABLE TO DETACH WITH INSTANT DETACHER. WHEN THE COIL WAS PULLED ABOUT 3 CENTIMETRES, IT WAS DETACHED. THE DEVICE PREPARED ACCORDING TO THE INSTRUCTIONS PER THE IFU. THERE WAS NOT ANY PATIENT INJURY REPORTED. NO IMAGES AVAILABLE FOR REVIEW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604478 ↗
• MalfunctionJul 5, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COILS DID NOT DETACH. THE PATIENT WAS UNDERGOING A VESSEL TAKE DOWN SURGERY TO TREAT A TUMOR. IT WAS STATED THAT THE FIRST COIL DID NOT DETACH. AS A RESULT A SECOND COIL OF THE SAME SIZE AND LOT NUMBER WERE USED WHICH ALSO FAILED TO DETACH. THE HEALTHCARE PROFESSIONAL (HCP) ATTEMPTED TO DETACH THE COIL 4 TIMES WITH THE INSTANT DETACHER AND 2 TIMES WITH A MANUAL METHOD, WITH NO OTHER INSTANT DETACHER ATTEMPTED, BUT THE ISSUE WAS UNRESOLVED. NO ISSUE WITH THE INSTANT DETACHER WAS NOTED. THERE WERE NO RELATED PATIENT SYMPTOMS. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT HAD A NORMAL VESSEL TORTUOSITY. THE PATIENT WAS ULTIMATELY TREATED WITH A DIFFERENT COIL AND ARE CURRENTLY IN GOOD CONDITION. THERE WAS NO DAMAGE TO THE PUSHWIRE NOTED ONCE IT WAS REMOVED FROM THE PATIENT, AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7663656 ↗