AxiumTM APB-3-8-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00847536021242), received between Jun 20, 2018 and Mar 4, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT HAD RESISTANCE IN THE SHEATH DURING DELIVERY AND WAS STRETCHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM IN THE OPHTHALMIC ARTERY SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE ANEURYSM MAX DIAMETER WAS 3.2MM AND THE NECK DIAMETER WAS 2.9 MM. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT THE AXIUM PRIME ES SPRING COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE AVIGO MICRO-GUIDEWIRE NAVIGATED THE ECHELON10 MICROCATHETER TO THE ANEURYSM SAC, AND THE GUIDEWIRE WAS WITHDRAWN. THE COIL WAS INTRODUCED FOR EMBOLIZATION. HOWEVER, THE COIL DELIVERY WIRE COULD NOT BE ADVANCED THROUGH THE INTRODUCER SHEATH. THE INTRODUCER SHEATH AND COIL WERE SUBSEQUENTLY REMOVED TOGETHER FOR INSPECTION, REVEALING THAT THE COIL HAD BEEN STRETCHED. THE COIL WAS REPLACED, AND THE EMBOLIZATION WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICES: 8F GUIDING GUIDE CATHETER, ECHELON 10 MICRO CATHETER, AVIGO GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517389 ↗
• MalfunctionJan 25, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WERE NO ISSUES ENCOUNTERED PRIOR TO COIL NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584330 ↗
• MalfunctionJul 31, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION, THERE WAS A STRONG RESISTANCE INSIDE THE MICROCATHETER. IT WAS NOTED THAT WHEN THE DEVICE WAS COLLECTED, THE JOINT BETWEEN THE COIL AND THE DELIVERY WAS DAMAGED. THERE WAS NO DAMAGE TO THE CATHETER. ALL SUBSEQUENT COILS WERE INSERTED WITHOUT ANY PROBLEMS. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS FLUSHED AND THE COIL WAS HYDRATED PER THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430549 ↗
• MalfunctionDec 16, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING AN AXIUM COIL BREAK AND STUCK IN THE SHEATH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 5 MM NECK DIAM ETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT ON (B)(6) 2022, A 65-YEAR-OLD FEMALE UNDERWENT SURGERY AT THE (B)(4) HOSPITAL OF (B)(4).  DSA ANGIOGRAPHY CONFIRMED A POSTERIOR COMMUNICATING ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY, ABOUT 3-5MM. DURING THE ANEURYSM EMBOLIZATION SURGERY, THE SURGEON USED THE DETACHABLE SPRING COIL APB-3-8-3D-ES. WHEN THE COIL WAS PUSHED, IT BROKE, AND AFTER SUFFICIENT SALINE PERFUSION, IT STILL COULD NOT BE PUSHED OUT FROM THE PROTECTIVE SHEATH, AND COULD NOT BE PUSHED INTO THE LESION, MAKING IT UNUSABLE. THE SAME MODEL OF SPRING COIL WAS REPLACED WITH DURING THE SURGERY, AND IT SUCCESSFULLY REACHED THE LESION LOCATION AND THE SURGERY WAS COMPLETED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999655 ↗
• MalfunctionNov 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ATTEMPTS HAD BEEN MADE TO DETACH THE COIL BECAUSE IT HAD NOT REACHED THE INTENDED IMPLANT LOCATION. NO PUSHWIRE DAMAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15856511 ↗
• MalfunctionSep 13, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL COULD NOT BE DETECTED DURING THE PROCEDURE. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER COIL OF THE SAME SIZE THAT WAS USED WITHOUT ISSUE. NO PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411669 ↗
• MalfunctionMay 6, 2022Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A BREAKAGE OBSERVED TO THE COIL WHEN THE BAG WAS OPENED. THE COIL WAS NOT USED IN THE PATIENT'S BODY. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. IT WAS UNKNOWN IF THERE WAS DEFORMATION OR DAMAGE TO THE DELIVERY PUSHER. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE LEFT IC-PC WITH A MAX DIAMETER OF 5MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14298280 ↗
• MalfunctionAug 13, 2021Break; Packaging Problem; Break; Packaging Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS RESISTANCE NOTICED WHEN THEY REMOVED THE PRODUCT FROM THE HOOP, SO IT WAS NOT DELIVERED. THE FLUSH WAS NOT PERFORMED BECAUSE THE ISSUE OCCURRED BEFORE IT WAS REMOVED FROM THE HOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12319411 ↗
• MalfunctionDec 8, 2020Migration; Physical Resistance/Sticking; Migration; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING 2 AXIUM COILS THAT HAD RESISTANCE IN THE CATHETER. THE SECOND COIL PUSHER BROKE AND PART OF THE FIRST COIL WAS FOUND TO BE OUTSIDE THE ANEURYSM. THE PATIENT WAS BEING TREATED FOR A RUPTURED AMORPHOUS ANEURYSM OF THE LEFT INTERNAL CAROTID ANTERIOR COMMUNICATING ARTERY WITH SUBARACHNOID HEMORRHAGE (SAH). THE ANEURYSM MAX DIAMETER WAS 4.5MM AND THE NECK DIAMETER WAS 2.25MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE AXIUM COIL (MODEL: APB-3-8-3D-ES) HAD RESISTANCE IN THE MIDDLE SECTION OF THE CATHETER BUT WAS ABLE TO BE SUCCESSFULLY IMPLANTED AND DETACHED. ANOTHER AXIUM COIL (MODEL: APB-2-4-3D-ES) WAS THEN USED. THE 2X4 COIL ALSO HAD RESISTANCE IN THE CATHETER AND BECAME STUCK IN THE DISTAL END OF THE CATHETER. THE DISTAL SEGMENT OF THE 2X4 PUSHWIRE BROKE WITH THE COIL STILL WITHIN THE CATHETER. THERE WAS NO ATTEMPT TO DETACH THE 2X4 COIL. THE PHYSICIAN DID NOT ROTATE THE PUSHER DURING DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. IT WAS UNCERTAIN IF THE CATHETER WAS DAMAGED BY THE 3X8 COIL OR IF THERE WAS AN ISSUE WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10968882 ↗
• MalfunctionAug 17, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION REGARDING ANEURYSM LOCATION. ANEURYSM LOCATED IN ANTERIOR COMMUNICATING ARTERY, SIZE:6.5*5.3*5.3MM. THE VESSEL WAS MODERATE TO SEVERE TORTUOUS. THERE WAS NOT ANY KINK/DAMAGE TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10414817 ↗
• MalfunctionMar 19, 2020Incomplete or Missing Packaging; Detachment of Device or Device Component; Incomplete or Missing Packaging; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS DETACHED UPON OPENING THE COVER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND NO PATIENT HARM INDICATED.

  Patient problems: No Patient Involvement

  MAUDE report 9853549 ↗
• MalfunctionJan 27, 2020Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED, LEFT DISTAL ANTERIOR CEREBRAL ARTERY (DACA) ANEURYSM WITH A MAX DIAMETER OF 3.4MM AND A 1.2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE AXIUM COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER, AND WHILE PULLING IT BACK, THE COIL BECAME STRETCHED AT THE PUSHWIRE DISTAL SEGMENT. THERE WAS NO FRICTION/DIFFICULTY DURING TESTING OR DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE OR ATTEMPT TO DETACH THE COIL, BUT IT WAS REMOVED FROM THE PATIENT WITH THE HELP OF THE MICROCATHETER AS IT WAS DETACHED INSIDE. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9634333 ↗
• MalfunctionNov 28, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING TREATMENT OF UNRUPTURED SACCULAR ANEURYSM LOCATED IN P-COMM MEASURING 4 MM X 2 MM, THE MEDTRONIC IMPLANT COIL STUCK AT THE CATHETER HUB. THE IMPLANT COIL WAS REPORTED TO BE ABLE TO BE PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH. THERE WERE NOT ANY PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NEW COIL WAS REPLACED WITH ANOTHER COIL AND PROCEDURE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8113165 ↗
• MalfunctionNov 21, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF A SMALL UNRUPTURED SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM, MEASURING 5MMX3.5MM, COIL STUCK IN PROXIMAL PART OF THE CATHETER DURING THE PROCEDURE. YES, THE IMPLANT COIL WAS PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH. 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 MODERATELY TORTUOUS. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT INJURY WAS REPORTED. THE CATHETER WAS NOT DAMAGED. THE COIL WAS NOT DAMAGED. YES, THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. AFTER THE AXIUM REMOVED PROF. YOON DID ADDITIONAL COIL INSERTION AND PATIENT WAS TREATED. 6F ENVOY, SL-10 MICROCATHETER, SYNCHRO 14 ¿ ACCESSORY DEVICES WERE DISCARDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8094917 ↗
• MalfunctionJun 20, 2018Detachment Of Device Component; Detachment Of Device Component

  MEDTRONIC RECEIVED INFORMATION THAT DURING COILING TREATMENT OF UNRUPTURED, SACCULAR POSTERIOR COMMUNICATING ARTERY ANEURYSM, THIS COIL STRETCHED DURING THE PROCEDURE AND DETACHED ITSELF INSIDE THE ANEURYSM. IT WAS REPORTED THAT THE COIL STRETCH OCCURRED IN CASE, MAYBE NOT A COIL STRETCHED ITSELF, JUST STRAND RESIST WIRE WAS STRETCHED, BUT IT WAS DETACHED LATER. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THE PROCEDURE COMPLETED SUCCESSFULLY. 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. NO PATIENT INJURY WAS REPORTED. REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS NOT ANY FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. YES, THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. ANY ACCESS OR ASSOCIATED DEVICES USED - ASKED BUT WILL NOT BE MADE AVAILABLE (LEGAL/CONFIDENTIAL REASON) ONLY COIL'S DELIVERY WIRE WILL BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7622673 ↗