Axium PrimeTM APB-1-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536031821), received between May 26, 2021 and Jan 16, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THERE WERE ANY NO DETACHMENT ATTEMPTS (INSTANT DETACH OR MANUAL METHOD) MADE. THERE WAS NO KI NK/DAMAGE OBSERVED ON THE PUSHWIRE. THERE WERE 2 COILS IMPLANTED BEFORE AND 2 COILS IMPLANTED AFTER THIS MALFUNCTIONED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18517575 ↗
• MalfunctionNov 28, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING ONE AXIUM COIL (LOT# 224405948) WAS FOUND STRETCHED AND ONE AXIUM COIL (LOT# B153311) DETACHMENT FAILURE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4 MM AND A 2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE ANEURYSM EMBOLIZATION WAS PERFORMED. AFTER THE MICROCATHETER WAS IN PLACE, THE AXIUM COIL (LOT# 224405948) SPRING COIL WAS SELECTED AND USED, AND THE SPRING COIL WAS STRETCHED. REPLACING WITH ANOTHER HOOP THAT WAS FORMED, THE AXIUM COIL (LOT# B153311) WAS SELECTED FOR FILLING AND COULD NOT BE DETACHED. AFTER MANY ATTEMPTS, IT WAS WITHDRAWN. THE SPRING COIL WAS DETACHED IN THE BODY AND AFTER REPLACING WITH ANOTHER SPRING COIL, THERE WAS NO PROBLEM AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15870203 ↗
• MalfunctionAug 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED IN THE SHEATH WHILE THE COIL WAS DELIVERED TO THE MICROCA THETER. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PUSHWIRE WAS NOT BENT/BROKEN, THERE WAS NO FRICTION/DIFFICULTY DURING DELIVERY, THE PHYSICIAN DID NOT REPOSITION THE COIL, NO DETACHMENT ATTEMPTS HAD BEEN MADE, AND THE PHYSICIAN DID NOT ROTATE THE PUSHER. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 4MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE AN ENVOY 6F GUIDE CATHETER, HEADWAY 17 MICROCATHETER, AND SYNCHRO 14 GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15332331 ↗
• MalfunctionAug 10, 2022Stretched; Stretched

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT WAS NOTED TO HAVE WIRE DRAWING DURING DETACHMENT. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A 3.5MM SACCULAR ANEURYSM WITH NECK DIAMETER OF 4.2MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN DETACHING THE COIL, IT WITHDREW WIRE. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE "WITHDREW WIRE" WAS REFERRING TO A COIL STRETCH. THE COIL WAS REMOVED FROM THE PATIENT. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202129 ↗
• MalfunctionJan 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED OUT OF THE SHEATH BEFORE USE. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED OF THE POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM WITH A MAX DIAMETER OF 5.3 MM AND A 3.7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214870 ↗
• MalfunctionOct 27, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE MICROCATHETER. THERE WAS NO DAMAGE TO THE CATHETER. THE COIL WAS NOT USED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, FUSIFORM ANEURYSM LOCATED IN THE RIGHT OPHTHALMIC ARTERY SEGMENT. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 5MM. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. ADDITIONAL INFORMATION RECEIVED INDICATED THE COIL PUSHED OUT OF THE SHEATH SMOOTHLY, AND THE CATHETER WAS AN UNKNOWN MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708681 ↗
• MalfunctionSep 29, 2021Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR OCCIPITAL ANEURYSM WITH A MAX DIAMETER OF 3MM AND A 2MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COILS WERE PLACED INTO THE ANEURYSM. THE COIL WOULD NOT DETACH USING THE DETACHMENT DEVICE. THE COIL WOULD NOT DETACH USING THE MANUAL METHOD. WHEN ATTEMPTING TO REMOVE THE COIL, IT DETACHED WITHIN THE MICROCATHETER. THE COIL SEPARATED/BROKE/PREMATURELY DETACHED. THE COIL WAS REMOVED FROM THE PATIENT WITHIN THE MICROCATHETER WITH THE MICROCATHETER. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE MICROCATHETER NEEDED TO BE REMOVED AND REPLACED. THERE WAS NO FRICTION OR DIFFICULTY DURING THE DELIVERY. IT WAS UNKNOWN IF THE PHYSICIAN REPOSITIONED THE COIL. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2-3 TIMES. THE MANUAL METHOD FOR DETACHING THE COIL WAS ATTEMPTED 2 TIMES. IT WAS UNKNOWN IF THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE. A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DEVICE AND ACCESSORY WAS PREPARED AS INDICATED IN THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12547828 ↗
• MalfunctionSep 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED SACCULAR ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY COMMUNICATING SEGMENT. THE ANEURYSM MEASURED SMALLER THAN 8MM. VESSEL TORTUOSITY WAS NORMAL.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL DETACHED PREMATURELY. THE COIL WAS COLLECTED AND REMOVED FROM THE PATIENT USING A SOLITAIRE. IT WAS NOTED THAT THE AXIUM COIL AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO FRICTION OR OTHER DIFFICULTY DURING DELIVERY OF THE COIL. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE PHYSICIAN DID NOT REPOSITION OR ATTEMPT TO DETACH THE COIL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12452802 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT DURING THE EMBOLIZATION PROCESS, THE AXIUM COIL WAS AUTOMATICALLY DETACHED IN THE MICROCATHETER. THE DETACHMENT ROD WAS COMPLETED AND WITHDRAWN, AND THE COIL WAS PUSHED INTO THE EMBOLIZATION SITE WITH A GUIDE WIRE. IT WAS NOTED THE COIL WAS NOT IMPLANTED IN THE INTENDED LOCATION, BUT THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS NO DAMAGE TO THE PUSHWIRE, NO FRICTION DURING DELIVERY, NO DETACHMENT ATTEMPTS MADE, NO REPOSITIONING OF THE COIL, NO ROTATION OF THE PUSHWIRE, AND NO CONTINUOUS FLUSH USED. 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. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF NEUROVASCULAR ABNORMALITIES NOT LOCATED IN AN ELOQUENT REGION. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE MICROCATHETER AND GUIDEWIRE USED IN THE EVENT WERE NON-MEDTRONIC PRODUCTS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11885681 ↗