AxiumTM APB-3-6-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536021082), received between Jan 3, 2019 and May 3, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT ACCORDING TO THE DOCTOR, THERE WAS NO PROBLEM PRIOR TO THE NON-DETACHMENT, AND THE COIL WAS DETACHED BY THE EMERGENCY DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239489 ↗
• MalfunctionMay 3, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT ACCORDING TO THE DOCTOR, THERE WAS NO PROBLEM PRIOR TO THE NON-DETACHMENT, AND THE COIL WAS DETACHED BY THE EMERGENCY DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239485 ↗
• MalfunctionSep 18, 2023Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE DELIVERY WIRE WAS BROKEN WHEN IT WAS OPENED. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765960 ↗
• MalfunctionJun 12, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE PROFESSOR PUT IN THE COIL THROUGH THE SL-10 CATHETER AND THE COIL WAS STRETCHED SO THE PROFESSOR REMOVED THE COIL AND CHANGED TO A NEW COIL SUCCESSFULLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS NOTED THAT THERE WAS NO PATIENT INVOLVED IN THE EVENT. ANCILLARY DEVICES INCLUDE A SL-10 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107061 ↗
• MalfunctionJun 28, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A FRAME WAS CREATED USING TARGET360ULTRA, AND WHEN THE PRODUCT WAS INSERTED, DETACHMENT WAS NOT POSSIBLE. EVEN WHEN THE WIRE WAS FOLDED DETACHMENT WAS NOT POSSIBLE, SO THE PRODUCT WAS COLLECTED. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER SEVERAL TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE ONE TIME. A SECOND AXIUM COIL WAS INSERTED AND AN ATTEMPT WAS MADE TO PLACE THE PRODUCT, HOWEVER, THE COIL WAS STUCK AT THE CATHETER HUB. THE COIL WAS COLLECTED AND THE PROCEDURE WAS FINISHED. THE COIL SMOOTHLY EXTENDED FROM THE INTRODUCER SHEATH. IT WAS UNKNOWN IF THE CATHETER OR COIL WERE DAMAGED DURING THE ATTEMPT. THERE WAS NO HEALTH DAMAGE PRESENT. THE PATIENT'S BLOOD FLOW SPEED WAS UNKNOWN AND THE DEGREE OF VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE: PHENOM17 MICROCATHETER AND CHIKAI14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843958 ↗
• MalfunctionOct 19, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE RELATED TO A RUPTURED AMORPHOUS ANEURYSM OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 2-3MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COIL WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THE COMPLAINT COIL WAS THE FOURTH TO BE USED IN THE PROCEDURE. THE PHYSICIAN ATTEMPTED 4 OR 5 TIMES TO DETACH THE COIL WITH THE INSTANT DETACHER WITHOUT SUCCESS. IT WAS NOTED THERE WAS NO PROBLEM WITH THE INSTANT DETACHER. MANUAL DETACHMENT WITH THE HYPOTUBE WAS ALSO ATTEMPTED ONCE WITHOUT SUCCESS. FINALLY THE COIL WAS REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661761 ↗
• MalfunctionJun 7, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11951860 ↗
• MalfunctionJun 2, 2021Unintended Movement; Physical Resistance/Sticking; Unintended Movement; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO PARTICULAR CATHETER KICKBACK. THERE WAS NO KINK OR OTHER DAMAGE NOTED TO THE COIL AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11924011 ↗
• InjurySep 24, 2020Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S PARALYSIS REMAINED AND THEY WERE REHABILITATING.

  Patient problems: Hematoma; Paralysis

  MAUDE report 10580187 ↗
• MalfunctionJul 29, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT, AFTER PUSHING A SMALL DISTANCE, THERE WAS LARGE RESISTANCE BETWEEN THE MICROCATHETER AND COIL. THE ISSUE PERSISTED DESPITE MULTIPLE ATTEMPTS. IT WAS NOTICED THAT THE COIL WAS DAMAGED, AND THAT THE PUSHER WAS KINKED/BROKEN. AS A RESULT THE DEVICE WAS REPLACED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RUPTURED, AMORPHOUS ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A NECK DIAMETER OF 3.8MM. IT WAS NOTED THAT THE BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. A CONTINUOUS FLUSH WAS USED. ANCILLARY DEVICES INCLUDE A NAVIEN 6F 115CM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8839291 ↗
• MalfunctionJan 3, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE IMPLANT COIL COULD NOT BE DETACHED WITH AN INSTANT DETACHER SO ANOTHER INSTANT DETACHER WAS USED ON THE SAME COIL, BUT IT STILL WOULD NOT DETACH. THE IMPLANT COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S VESSEL TORTUOSITY AND VESSEL DIAMETER WAS UNKNOWN. ANCILLARY DEVICE: ST10 STR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8213750 ↗