AxiumTM APB-2-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00847536021181), received between Jan 28, 2019 and Aug 25, 2025 — classified as 1 death, 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED. NO DETACHMENT ATTEMPTS WERE MADE USING EITHER THE INSTANT DETACHER OR MANUAL METHODS. THERE WERE NO ISSUES THAT RESULTED IN THE OBSERVED DAMAGE. THE CAUSE OF THE PREMATURE DETACHMENT OR DAMAGE WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22890771 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT ON DECEMBER 16 (MONDAY), TREATMENT WAS PERFORMED FOR AN UNRUPTURED ANEURYSM WITH AN IC OF 6-7 MM. PREOPERATIVE PLAN WAS AFTER PLACING 2 COILS WITH BALLOON ASSIST, THE MICROCATHETER WILL BE REPLACED AND THE PIPELINE WILL BE PLACED. THE RIST WAS SUCCESSFULLY GUIDED SMOOTHLY TO THE VICINITY OF THE CAVERNOUS AREA. AN ATTEMPT WAS MADE ABOUT 3 TIMES TO ACCESS THE ANEURYSM, AND THE MICROCATHETER WAS SUCCESSFULLY PLACED IN THE ANEURYSM. ONE APB-3-8-3D AND ONE APB-3-6-3D WERE PLACED WITH BALLOON ASSIST. UPON PERFORMING A CONTRAST IMAGING USING THE RIST, DECREASED PERIPHERAL BLOOD FLOW WAS FOUND (PERIPHERAL FROM M3). HEALTHCARE PROVIDER (HCP) COMMENTED THAT THERE WAS A POSSIBILITY THAT A THROMBUS MIGHT HAVE RELEASED WHEN INDUCED TO AN ANEURYSM USING THE MICROCATHETER. PIPELINE PLACEMENT WAS DISCONTINUED AT THE DISCRETION OF THE HCP. RE-TREATMENTIS SCHEDULED AT A LATER DATE AFTER RECOVERY OF BLOOD FLOW. 2 APB-2-3-3D WERE ADDED, AND THE PROCEDURE WAS COMPLETED. ON MARCH 10 (MONDAY), IT WAS REPORTED THAT A PATIENT IN 40S DEVELOPED A HIGH-LEVEL FUNCTIONAL DISORDER. DETAILS ARE UNKNOWN, BUT THE SYMPTOMS ARE SPEECH IMPAIRMENT AND LOWER HALF OF THE BODY PARALYSIS. T

  Patient problems: Air Embolism; Dysphasia; Nervous System Injury; Paralysis; Reduced Blood Flow

  MAUDE report 21634704 ↗
• MalfunctionJun 14, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. MANUAL DETACHMENT, NO INSTANT DETACHER USED. 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 19537625 ↗
• MalfunctionApr 3, 2024Separation Failure; Material Deformation; Separation Failure; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT TREATMENT OF AND ANEURYSM OF THE INTERNAL CAROTID ARTERY POSTERIOR COMMUNICATING ARTERY. VESSEL TORTUOSITY WAS NORMAL. THE PATIENT HAD NO PROBLEMS WITH RECOVERY AND DIDN'T EXPERIENCE ANY SYMPTOMS RELATED TO THE EVENT. PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. IT WAS NOTED THAT THE PUSHWIRE WAS BENT A LITTLE AS IT WAS PUSHED/PULLED BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032493 ↗
• DeathApr 24, 2023Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORT THE PATIENT DIED IN THE INTENSIVE CARE UNIT (ICA). IT WAS NOTED THAT THE PATIENT'S DEATH WAS "DUE TO ANOTHER PATHOLOGY" AND WAS NOT RELATED TO THE AXIUM COIL DETACHMENT ISSUES.

  Patient problems: Obstruction/Occlusion; Stroke/CVA

  MAUDE report 16803544 ↗
• MalfunctionMar 15, 2023Break; Incomplete or Missing Packaging; Detachment of Device or Device Component; Break; Incomplete or Missing Packaging; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THE MARKER WAS MISSING WHEN THE PACKAGE WAS OPENED. THE PRE-DETACHMENT OF THE COIL HAPPENED INSIDE THE MICROCATHETER AND WAS REMOVED IN A WHOLE SYSTEM. IN ADDITION, THE PHYSICIAN UPDATED THAT THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16545959 ↗
• MalfunctionFeb 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD NO PROBLEM WITH RECOVERY. THERE WERE NO SYMPTOMS RELATED TO THE COIL SEPARA TION/PREMATURE DETACHMENT. THE COIL WAS IMPLANTED. THE CATHETER WAS A HEADWAY 17. IT WAS UNKNOWN IF THE COIL WAS IMPLANTED IN THE INTENDED LOCATION OR IF MEDICAL/SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16398920 ↗
• MalfunctionApr 19, 2022Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE COIL PUSHER WIRE WAS BROKEN WHEN THE PRODUCT WAS ADVANCED INSIDE THE MC, EARLY DETACHMENT OCCURRED. DAMAGE WAS IN THE PUSHER DISTAL REGION. THERE WAS NO RESISTANCE DURING PREPARATION OR USE. THE DEVICE WAS PREPARED AS INDICATED IN THE PACKAGE INSERT AND THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14153008 ↗
• MalfunctionMar 8, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT FAILED TO DETACH. THAT PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR BASILAR ARTERY TIP ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 6.83MM AND THE NECK DIAMETER WAS 3MM. BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED DETACHMENT WITH THE INSTANT DETACHER (ID) TWICE WITHOUT SUCCESS; ANOTHER ID WAS NOT TRIED. IT WAS NOTED THERE WAS NO ISSUE WITH THE ID. TWO ATTEMPTS WERE ALSO MADE TO DETACH THE COIL MANUALLY WITH THE HYPOTUBE WITHOUT SUCCESS. THE COIL WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688681 ↗
• MalfunctionAug 20, 2021Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Material Deformation; Difficult or Delayed Positioning; Stretched; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DETACHED EARLY AND DEVIATED FROM THE ANEURYSM. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE INTERNAL CAROTID-POSTERIOR COMMUNICATING (I C-PCOM) ANEURYSM. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT WHEN THE FOURTH COIL WAS PLACED THERE WAS A SLIGHT DEVIATION FROM THE OUTSIDE OF THE ANEURYSM. INSERTION WAS COMPLETED AFTER INSERTING AND REMOVING IT TWICE. THE COIL WAS APPROPRIATELY DETACHED WITH A DETACHER, BUT WHEN THE DELIVERY PUSHER WAS PULLED OUT, IT WAS SUSPECTED TO BE STRETCHED. THE MICROCATHETER WAS ALSO REMOVED ON THE ASSUMPTION THAT SOMETHING REMAINED IN THE MICROCATHETER; HOWEVER, THE THIRD COIL DEVIATED FROM THE ANEURYSM SO IT WAS COLLECTED WITH A SNARE. THERE WAS COIL DAMAGE/EARLY DETACHMENT. NO ADDITIONAL MEDICAL/SURGICAL INTERVENTIONS WERE NEEDED. THERE WAS NO DAMAGE TO THE DELIVERY PUSHER, AND THERE HAD BEEN NO RESISTANCE DURING DELIVERY. THE COIL HAD BEEN REPOSITIONED TWICE, AND NO DETACHMENT ATTEMPTS WERE MADE. THE PUSHER WAS NOT ROTATED INSIDE THE PATIENT'S BODY. A CONTINU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12349078 ↗
• MalfunctionJun 7, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952048 ↗
• MalfunctionApr 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED DURING PREPARATION. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THE PATIENT WAS NOT AFFECTED AS THE EVENT OCCURRED PRIOR TO USE. THERE WERE NO ABNORMALITIES IN THE APPEARANCE OF THE DEVICE PACKAGE. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695666 ↗
• MalfunctionDec 23, 2019Stretched; Separation Failure; Stretched; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH AND THE WIRE STRETCHED. THE INSTANT DETACHER WAS USED TWICE. A SECOND DETACHER WAS NOT USED. ONE MANUAL DETACHMENT WAS MADE. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE ANATOMY WAS MODERATE IN TORTUOSITY, AND THE BLOOD FLOW WAS NORMAL. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT MCA 3MM SACCULAR, UNRUPTURED ANEURYSM. THE MAX DIAMETER WAS 3MM AND THE NECK WAS 1.5MM. NO PATIENT INJURY OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511924 ↗
• MalfunctionSep 24, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THE AXIUM COIL FAILED TO DETACH WITH 2 INSTANT DETACHERS AND MANUAL DETACHMENT. 3 ATTEMPTS WERE MADE WITH ONE INSTANT DETACHER AND 2 TIMES WITH A SECOND DETACHER. ONE MANUAL DETACHMENT ATTEMPT WAS MADE BUT THIS ALSO FAILED. THE DEVICE WAS REMOVED, AND A NEW COIL WAS USED. NO PATIENT INJURY OCCURRED. THE BLOOD FLOW WAS NORMAL. THE VESSEL ANATOMY WAS MINIMAL IN TORTUOSITY. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THIS EVENT OCCURRED DURING THE TREATMENT OF A C6, UNRUPTURED, SACCULAR ANEURYSM. THE MAX DIAMETER WAS 3MM AND THE NECK DIAMETER WAS 2MM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9109193 ↗
• MalfunctionJun 27, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM PRIME ENCOUNTERED RESISTANCE WHEN ATTEMPTED TO BE ADVANCED OUT. THE COIL WAS INITIALLY ABLE TO BE PUSHED OUT OF THE SHEATH PER THE IFU AND FLUSHED. THE COIL WAS PULLED BACK INTO THE SHEATH AND THE SHEATH WAS THEN INSERTED INTO THE Y-CONNECTION OF THE HEADWAY 17 CATHETER HUB TO ATTEMPT TO DELIVER THE COIL, BUT THE COIL WAS TOO STIFF TO PUSH FORWARD. THEY REMOVED THE INTRODUCER SHEATH FROM THE CATHETER HUB AND ATTEMPTED TO PUSH THE COIL OUTSIDE BODY, BUT THE COIL COULD NOT COME OUT AS WELL. THEY TRIED TO PULL THE PUSHWIRE CONVERSELY FROM THE SHEATH PROXIMAL AND THE COIL WAS ABLE TO BE PULLED OUT OF THE SHEATH WITHOUT RESISTANCE. THEY WERE ABLE TO PUT THE COIL INTO THE SHEATH AGAIN FROM THE PUSHWIRE PROXIMAL AND PUSHED THE PUSHWIRE. WHEN THEY WERE ALMOST TO PUSH THE COIL OUT OF THE TIP OF THE SHEATH, THE RESISTANCE WAS STILL STRONG AND FAILED TO PUSH IT OUT. WHEN THEY PUT THE COIL INTO THE SHEATH FOR THE SECOND TIME, THEY FELT A LITTLE BIT OF RESISTANCE AND STIFFNESS WHICH WAS DIFFERENT FROM USUAL. THEY CHECKED IF THERE WAS BREAKAGE ON THE COIL IMPLANT PART AND DID NOT FIND ABNORMALITY. FOR THE ABOVE REASONS, THEY OPENED ANOTHER NEW PRODUCT AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739536 ↗
• MalfunctionApr 20, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT OF AXIUM COIL MARKER DISLODGE. THE PATIENT WAS UNDERGOING A COILING PROCEDURE. THE REPORTED DEVICE AND THE ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS USED DURING THE CASE. IT WAS REPORTED THAT ONE AXIUM COIL WAS IMPLANTED IN THE PATIENT. DURING PLACEMENT, THE COIL ALIGNMENT MARKER WAS NOTED TO BE NOT ALIGNED TO THE CATHETER MARKER. THERE WAS REPORTEDLY NO DAMAGE TO THE PUSHWIRE. NEXT, A SECOND AXIUM COIL WAS ATTEMPTED TO BE PLACED. THE COIL ENCOUNTERED RESISTANCE IN THE CATHETER AND THERE WAS NOTED TO BE A "DOT-SHAPED MARKER". THE SECOND COIL WAS NOT IMPLANTED. NO MORE COILS WERE ATTEMPTED. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8534291 ↗
• MalfunctionApr 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF A SMALL RUPTURED SACCULAR ANEURYSM LOCATED IN ANTERIOR COMMUNICATING ARTERY, MEASURING 4MMX2MM, THESE BOTH COILS FELT RESISTANCE WHILE PUSHING INSIDE THE HUB OF THE MICROCATHETER. EVEN THERE WAS A RESISTANCE WHEN PREPARING COILS ACCORDING TO IFU. THERE WAS ALSO SLIGHT RESISTANCE WHEN THE COILS WERE PUSHED FROM THE INTRODUCER SHEATH. THE PATIENT WAS ULTIMATELY TREATED WITH OTHER AXIUM COILS. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO IMAGES AVAILABLE FOR REVIEW. THE PATIENT¿S BLOOD FLOW WAS NORMAL. THE VESSEL WAS NORMAL TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8504075 ↗
• MalfunctionJan 28, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THE AXIUM IMPLANT COIL COULD NOT BE DETACHED DESPITE SEVERAL ATTEMPTS. THE COIL WAS REMOVED FROM THE MICROCATHETER AND IT WAS NOTICE THAT AN UNWANTED DETACHMENT OF THE IMPLANT COIL HAD OCCURRED IN THE MICROCATHETER. NO PATIENT INJURY WAS REPORTED BECAUSE OF THE EVENT. A NEW CATHETERIZATION WAS PERFORMED WITH A NEW MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8282396 ↗