Axium PrimeTM APB-3-4-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00847536031920), received between Aug 25, 2021 and Jul 31, 2023 — 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 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.

• MalfunctionJul 31, 2023Stretched; Stretched

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL BECAME STRETCHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3.79 MM. THE NECK DIAMETER WAS 3.68 MM. THE PATIENT¿S BLOOD FLOW WAS NORMAL, AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT IN THE PROCESS OF DEPLOYING AND RECAPTURING THE FIRST COIL, THE COIL WAS STRETCHED AND PULLED OUT TOGETHER WITH THE CATHETER. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PHYSICIAN HAD REPOSITIONED THE COIL TWO TIMES. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN SL 10 S SHAPE MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL STAYED IN THE MICROCATHETER, WITH THE CAUSE OF THE STRESS BEING DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17429714 ↗
• MalfunctionJan 23, 2023Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT REGARDING AXIUM COIL RESISTANCE DUE TO A STRETCHED COIL. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE LEFT INTERNAL CAROTID CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 6.2 MM AND A 4.2 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT WHEN THE SPRING COIL WAS PUSHED INTO THE MICROCATHETER, THE RESISTANCE WAS RELATIVELY LARGE, AND IT WAS FOUND TO BE STRETCHED AFTER WITHDREW. THE AXIUM COIL 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. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE PROXIMAL SECTION OF THE CATHETER. THE TIP END HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS AN MDDTRONIC ECHELON10. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225064 ↗
• MalfunctionJun 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS LOCATED IN THE PARENT ARTERY AFTER THE THIRD LOOP AND THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL BUT IT DID NOT CHANGE. IT WAS NOTICED THE COIL WAS PRE-DETACHED, THE PHYSICIAN ATTEMPTED TO PUSH THE REMAINED COIL IN THE ANEURYSM. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION. THERE WERE NO SURGICAL OR MEDICINAL INTERVENTIONS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL ONCE. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE AND A CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE PUSHWIRE WAS NOT BENT OR BROKEN. THE DEVICES WERE PREPARED AS INDICATEDIN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 3.8MM AND AN UNKNOWN NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14763811 ↗
• MalfunctionMay 9, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT AN AXIUM COIL HAD RESISTANCE IN A MICROCATHETER AND THEN FAILED TO DETACH. THE PATIENT WAS TREATED FOR AN UNRUPTURED SACCULAR ANEURYSM IN THE ANTERIOR AND POSTERIOR COMMUNICATING ARTERIES. THE MAX DIAMETER WAS 3.2MM AND THE NECK DIAMETER WAS 3.0MM. VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).  HOSPITAL PERFORMED ANEURYSM SURGERY. THE LOCATION OF THE ANEURYSM WAS ANTERIOR AND POSTERIOR COMMUNICATING ANEURYSM. A WIDE-NECKED ANEURYSM WITH A TUMOR SIZE OF 3.0 × 3.2. AFTER THE GUIDE CATHETER WAS IN PLACE, THE COIL AND MICROCATHETER REACHED THE LESION, STARTED ANEURYSM EMBOLIZATION. THE FIRST CIRCLE USED AXIUM APB-3-4-3D-ES COIL AND NORMAL FLUSHED. HOWEVER; THE RESISTANCE WAS TOO LARGE DURING THE PUSH PROCESS. WHEN THE COIL WAS ALL SENT INTO THE ANEURYSM, DETACHED THE COIL MANY TIMES, BUT IT WAS NOT DETACHED. IN ORDER TO ENSURE THE SAFETY OF SURGERY, AFTER THE COIL WAS WITHDRAWN, REPLACED IT WITH A NEW COIL OF THESAME TYPE AND FILLED SMOOTHLY. FILLED IN THE APB-2-2-3D-ES, APB-1.5-2-3D-ES COIL IN TURN, SUCCESSFULLY FILLED. AFTER THE ANGIOGRAPHY, DENSE EMBOLISM, THE MICROCATHETER WAS WITHDRAWN. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14342926 ↗
• MalfunctionFeb 28, 2022Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED AFTER BEING UNABLE TO BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT OPHTHALMIC ARTERY. 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 ACCORDING TO THE NORMAL OPERATION PROCEDURE, THE FILLED COIL WAS UNSTABLE IN THE TUMOR. AFTER DEPLOYED THE STENT, THE EMBOLIZATION WAS CONTINUED. THE COIL WAS DETACHED ACCORDING TO THE STANDARD PROCEDURE. WHEN THE GUIDE WIRE WAS PUSHED, IT WAS FOUND THAT THE COIL WAS ALSO WITHDRAWN TOGETHER. AFTER REPEATEDLY ADJUSTED THE MICROCATHETER AND PUSHED THE GUIDE WIRE, IT STILL COULD NOT BE DETACHED. IT WAS DECIDED TO SLOWLY WITHDRAW IT FROM THE BODY, BUT THE COIL WAS DETACHED WHEN IT WAS HALFWAY BACK. AFTER DISCUSSION, IT WAS DECIDED TO WITHDRAW THE MICROCATHETER. WHEN THE MICROCATHETER WAS WITHDRAWN FOR A SHORT DISTANCE, THE COIL WENT OUT THE TIP OF THE MICROCATHETER MORE. IT WAS DECIDED TO USE A STENT AND A MICROCATHETER TO SUPPORT IT TO EXIT IT FROM THE BODY. THE COIL WAS REMOVED SUCCESSFULLY, AND THE PATIENT DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13619993 ↗
• MalfunctionFeb 3, 2022Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL HAD RESISTANCE AND WAS STRETCHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SA CCULAR, RUPTURED ANEURYSM IN THE BASILAR ARTERY WITH A MAX DIAMETER OF 4MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING INTERVENTIONAL EMBOLIZATION OF THE ANEURYSM, AFTER ECHELON 10 WAS IN PLACE, THE SURGEON CHOSE APB-3-4-3D-ES DETACHABLE COIL FOR EMBOLIZATION. WHEN THE DETACHABLE COIL WAS DELIVERED IN THE MICROCATHETER, THERE WAS OBVIOUS RESISTANCE. BASED ON THE SAFETY OF THE OPERATION, THE SURGEON PULLED THE COIL OUT OF THE BODY AND FOUND THAT THE COIL HAD BEEN STRETCHED. A NEW COIL WAS REPLACED, AND THE OPERATION PROCEEDED SMOOTHLY. THE OPERATOR BELIEVED THAT IT WAS A PRODUCT QUALITY PROBLEM AND REQUESTED IT TO BE RETURNED. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. ANCILLARY DEVICES INCLUDE A ECHELON 10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13447182 ↗
• MalfunctionJan 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL WAS PRE-DETACHED. THE DEVICE REMAINED IN THE PATIENT, NOT IMPLANTED AT THE INTENDED LOCATION. THE COIL WAS SECURED USING ANOTHER COIL TO PUSH THE PRE-DETACHED COIL AND THEN IT WAS DISCARDED. NO SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY AND THE COIL WAS NOT REPOSITIONED. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL OR ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. 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 ANEURYSM. 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 13227100 ↗
• MalfunctionNov 11, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED PRIOR TO COIL NON-DETACHMENT THERE WERE NO ISSUES ENCOUNTERED. PUSHWIRE DAMAGE WAS NOT OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800808 ↗
• MalfunctionAug 25, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS AUTOMATICALLY DETACHED DURING DELIVERY. THE COIL WAS REMOVED WITH THE MICROCATHETER, NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, THERE WAS NO DAMAGE TO THE PUSHED, NO REPOSITIONING OR ROTATION PERFORMED, NO DETACHMENT ATTEMPTS MADE, THERE WAS FRICTION DURING DELIVERY, AND A CONTINUOUS FLUSH WAS USED. A REPLACEMENT CATHETER WAS DELIVERED AND IMPLANTED WITH NO ISSUE. 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 AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 5.7 MM AND A 1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368801 ↗