AxiumTM APB-1.5-2-HX-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536020948), received between Dec 11, 2020 and Mar 30, 2026 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE PROXIMAL END OF THE PUSHWIRE SECURED IN THE GUIDEWIRE CLIP (BLACK RUBBER STOPPER) WHEN THE PACKAGE WAS OPENED. IT WAS UNABLE TO BE CONFIRMED IF THERE WAS ANY DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE DEVICE WAS NOT USED IN THE PATIENT AND WHEN THE PACKAGE WAS OPENED, IT WAS AS SEEN IN THE IMAGE. THE VESSEL TORTUOSITY IS UNKNOWN. THE CAUSES OR CONTRIBUTING FACTORS FOR THE BREAK WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24721105 ↗
• MalfunctionSep 16, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THREE DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER, AND NONE WERE MADE WITH THE MANUAL METHOD. THERE WERE NO PARTICULAR ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT. NO DAMAGE TO THE PUSHWIRE WAS OBSERVED. THE PATIENT HAD BEEN UNDERGOING TREATMENT FOR AN ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE SIZE WAS 6-7MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231339 ↗
• MalfunctionDec 27, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT IN AN ANEURYSM COILING CASE, THE ID-1-5 USED TO DETACH COIL DIDN'T WORK, THEN MANUAL DETACHMENT WAS PERFORMED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE ANEURYSM WAS SMALL, SACCULAR, DOME-2.5, HEIGHT-6, AICA ANEURYSM. VESSEL TORTUOSITY WAS SEVERE. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. THERE WERE 7 ATTEMPTS MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THERE WAS 1 ATTEMPT MADE TO DETACH THE COIL USING THE MANUAL METHOD. THE COIL WAS A MEDTRONIC DEVICE; AXIUM PRIME, LOT::226556149,227008032 <(>&<)> 227052961. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399251 ↗
• MalfunctionMar 3, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.3MM AND A 3.5MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT EMBOLIZATION WAS ASSISTED BY THE JOHNSON <(>&<)> JOHNSON EP STENT, APB-3-4, APB-2-6 HAD BEEN FILLED, AND THE REPORTED COIL OF APB1.5-2 WAS ALSO SUCCESSFULLY FILLED. HOWEVER, WHEN DETACHED, IT WAS FOUND THAT THE DETACHMENT WIRE COULD NOT BE PULLED, SO BROKE OFF FORWARD WITH HANDS AND TRIED TO PULL IT OUT, BUT IT COULD NOT BE PULLED. WITH THE ASSISTANCE OF HEMOSTATIC FORCEPS, THE DETACHMENT WIRE STILL COULD NOT BE PULLED. OBSERVED UNDER FLUOROSCOPY, THE COIL WAS NOT DETACHED, SO THE 1.5-2 COIL WAS WITHDRAWN AS A WHOLE, AND AN APB-1.5-2 COIL WAS REPLACED FOR IMPLANTATION, AND THE ANGIOGRAPHY WAS RECHECKED TO END THE OPERATION. IT WAS NOTED THAT THE BACKUP METHOD WAS USED MANY TIMES BUT THE COIL WAS NOT DETACHED. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477832 ↗
• MalfunctionJan 25, 2022Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED REPORT THAT WHEN THE AXIUM COIL (MODEL APB-2-2-HX-ES, LOT: B197786) WAS DELIVERED INTO THE ANEURYSM SAC, THE COIL COULD NOT BE DETACHED. THE COIL WAS REMOVED AND REPLACED. IT WAS OBSERVED THAT THE MIDDLE SEGMENT OF THE PUSHER WAS DAMAGED. THERE HAD NOT BEEN ANY FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL BUT THE PHYSICIAN DID ROTATE THE PUSHER. WHEN THE AXIUM COIL (MODEL: APB-1.5-2-HX-ES, LOT: 222087536) WAS BEING DELIVERED, THE TIP OF THE COIL WAS STRETCHED SO THE DEVICE WAS REMOVED AND REPLACED. IT WAS NOTED THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. THE PHYSICIAN DID NOT ROTATE THE PUSHER DURING THE DELIVER. INFORMATION IN THE REPORT ALSO INDICATED THAT BOTH COILS DETACHED PREMATURELY AS WELL; THE PHYSICIAN HAD NOT ATTEMPTED TO DETACH THE 1.5-2 COIL. IT WAS NOTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED FUSIFORM POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE ANEURYSM MAX DIAMETER 6.1MM AND THE NECK DIAMETER 3.9MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342839 ↗
• InjuryJul 27, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 2021-JUL-28. IT WAS NOT "DESTROYED", IT WAS DESCRIBED AS "CRUSHED", WHICH MEANT "BLOOD VESSEL CLOGGED". WHEN THE CATHETER WAS REMOVED, THE COIL BLOCK WAS SLIGHTLY DEFLECTED AND BLOOD FLOW TO THE ANTERIOR CHOROIDAL ARTERY STOPPED. AS FAR AS IT WAS SEEN AT THE SITE, THERE WAS NO ABNORMALITY/KINK/DAMAGE TO THE PUSHWIRE. THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION, IT WAS PARTIALLY DEVIATED FROM THE LUMP. SINCE THE STENT WAS SUPPOSED TO BE PLACED FROM THE BEGINNING, TWO ENTERPRISE WERE IMPLANTED AND THE DEVIATED COIL WAS PRESSED AGAINST THE VESSEL WALL. THE BLOOD FLOW TO THE ANTERIOR CHOROIDAL ARTERY HAD STOPPED, SO THERE MIGHT BE SOME KIND OF PROBLEM, BUT THE DETAILS REMAINED UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12229863 ↗
• MalfunctionJun 22, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO PARTICULAR DAMAGE OBSERVED TO THE AXIUM COIL PUSHWIRE. AFTER DETACHMENT OF THE COIL OCCURRED IN THE CATHETER, THE COIL WAS PUSHED INTO THE ANEURYSM LITTLE BY LITTLE USING A GUIDEWIRE AND MANAGED TO PUT IT ALL IN, THE PROCEDURE WAS COMPLETED. THE COIL IMPLANTATION POSITION WAS CLOSER TO THE NECK SIDE THAN ORIGINALLY INTENDED, BUT THERE SEEMED TO BE NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041860 ↗
• MalfunctionJun 7, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO PROBLEMS PRIOR TO THE COIL NON-DETACHMENT, AND THE COIL WAS IN A GOOD POSITION. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947461 ↗
• MalfunctionDec 11, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT TWO AXIUM COILS WOULD NOT GO INTO THE CATHETER HUB. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE PIARACHNOID AN WITH A MAX DIAMETER OF 6MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT TWO AXIUM COILS WOULD NOT GO INTO THE CATHETER HUB. 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. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE INTRODUCER SHEATH WAS NOT HELD VERTICALLY WHEN THE IMPLANT COILS WERE PULLED BACK INSIDE DURING HYDRATION. THE COILS CAME OUT OF THE INTRODUCER SHEATHS SMOOTHLY. NO DAMAGE WAS OBSERVED TO THE COILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991569 ↗