AxiumTM APB-1-3-3D-ESRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00847536021129), received between Apr 8, 2019 and Jun 1, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN AN ATTEMPT WAS MADE TO INSERT THE AXIUM PRIME BARE 3D COIL INTO THE NON-MEDTRONIC MICROCATHETER, THE IMPLANT COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH, HOWEVER, IT GOT STUCK IN THE HUB AND WOULDN'T GO IN. WHEN A DIFFERENT COIL WAS USED, IT WENT IN SMOOTHLY, SO THE PROCEDURE WAS PERFORMED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, RIGHT M1 SEGMENT ANEURYSM 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 MODERATE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE COIL OR CATHETER. ANCILLARY DEVICES INCLUDED SL-10 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. IT WAS ASKED BUT UNKNOWN IF THERE WAS ANY CAUSES OR CONTRIBUTING FACTORS FOR THE RESISTANCE WAS IDENTIFIED. THE INFORMATION HAS BEEN CONFIRMED/PROVIDED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351013 ↗
• MalfunctionNov 1, 2024Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE SPRING COIL WAS ALREADY DETACHED INSIDE THE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS NOT SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED. NO PREPARATION WAS DONE PRIOR TO THE DAMAGE THAT WAS FOUND. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING WHEN THE PACKAGE WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585106 ↗
• MalfunctionMay 20, 2024Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Unintended Movement; Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN WAS TREATING A BIZARRE SHAPED ANTERIOR COMMUNICATING ARTERY  ANEURYSM IN WHICH DE DECIDED TO DO PIPELINE VANTAGE FD ASSISTED COILING. AFTER DEPLOYING FD AND TWO COILS IN THIS ANEURYSM, THIS COIL WAS COMING OUT FROM THE ANEURYSM EVEN AFTER TRYING MANY TIMES. SO PHYSICIAN DECIDED TO TAKE OUT THIS COIL AND DID NOT DEPLOY MORE COILS. THERE WAS DIFFICULT PLACEMENT. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. NO ADDITIONAL STEPS OR SURGICAL INTERVENTION WAS REQUIRED TO REMOVE OR SECURE THE COIL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS NOT UNDER STRESS. THE TIP OF THE CATHETER DID NOT MOVE DURING DEPLOYMENT. THE ANEURYSM DID NOT RUPTURE. THE DEVICE AND ANY ACCESSORIES 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, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.4MM AND A 2.9MM 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 19354378 ↗
• MalfunctionMar 16, 2023Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Stretched; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE COIL WAS NOT BROKEN INTO MULTIPLE PIECES, IT WAS JUST STRETCHED AFTER TAKEN OUT. THE CATHETER HAD NO RESISTANCE. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. IT HAS BEEN REMOVED OUTSIDE THE BODY. THERE WAS NO KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE COIL WAS REMOVED AND FOUND IT STRETCHED. THERE WERE NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) MADE. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552769 ↗
• MalfunctionAug 10, 2022Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL PREMATURELY DETACHED IN THE SHEATH. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE RIGHT POSTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 3MM, AND THE NECK DIAMETER WAS 1MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COIL WAS REMOVED, AND NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR 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 DELIVERY PUSHER. A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. IT WAS OBSERVED THAT THE USE BEFORE DATE OF THE COIL WAS ON (B)(6) 2022, WHICH WAS PRIOR TO THE PROCEDURE. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN ENVOY 6F GUIDE CATHETER AND A HEADWAY 17 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201104 ↗
• MalfunctionApr 8, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT THREE IMPLANT COILS HAD DETACHMENT FAILURES WHEN USING THE INSTANT DETACHER (ID-1). THE AXIUM 1X3 AND 2.5X6 WERE DETACHED SMOOTHLY UPON USING THE MANUAL METHOD (BREAKING OF THE HYPOTUBE, AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE); HOWEVER, THE AXIUM 1.5X4 COULD NOT BE DETACHED BY THE MANUAL METHOD. THE COIL WAS THEN PULLED BACK INTO THE MICROCATHETER FOR REMOVAL AND SUDDENLY DETACHED INSIDE THE MICROCATHETER IN THE PROCESS. THE PUSHWIRE WAS REMOVED FROM THE MICROCATHETER AND A 0.001 GUIDEWIRE WAS INSERTED INTO THE SAME MICROCATHETER TO PUSH THE DETACHED COIL INTO THE ANEURYSM AS INTENDED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT FOR A 7MM ANEURYSM IN VASCULATURE THAT WAS MEDIUM IN TORTUOSITY. IT WAS NOTED THAT THE COILS WERE PERFORMED WITH FLUSHING TO AIR FLUSH AND THERE WAS NO RESISTANCE AT THE TIME OF INSERTION; HOWEVER, THE BREAK INDICATOR CUT WORSE THAN BEFORE AND DID NOT FEEL RIGHT DURING THE PROCESS OF DETACHMENT USING THE MANUAL METHOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490198 ↗