Axium PrimeTM APB-5-15-3D-SSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536032040), received between Jul 28, 2020 and Mar 27, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2023Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER RESISTANCE WAS IN THE DISTAL PORTION. THE COIL COME OUT OF THE INTRODUCER SHEATH. AFTER REMOVAL COIL WAS LITTLE KINKED. THE CATHETER WAS USED BY COMPETITION COMPANY. 2/3 TIME ATTEMPTS WERE MADE BY USING THE INSTANT DETACHER METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16623051 ↗
• MalfunctionMay 18, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN DELIVERING THE COIL TO THE MICROCATHETER, THE COIL COULD NOT BE PUSHED UP IN THE PROTECTIVE SHEATH AND THE RESISTANCE TO PUSH THE COIL INTO THE MICROCATHETER WAS HUGE. THE COIL WAS REPLACED WITH THE SAME TYPE OF PRODUCT AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14430849 ↗
• MalfunctionMay 26, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL COULD NOT BE PUSHED OUT OF THE SHEATH. THE PHYSICIAN FELT MUCH RESISTANCE WHEN ATTEMPTING TO ADVANCE THE COIL. 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 ANEURYSM EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889976 ↗
• MalfunctionApr 23, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WOULD NOT DETACH. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE ANTERIOR COMMUNICATING ARTERY. THE MAX DIAMETER WAS 5MM, AND THE NECK DIAMETER WAS 2MM. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THE VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT FOUR DETACHMENT ATTEMPTS HAD BEEN MADE WITH THE INSTANT DETACHER (ID), AND TWO ATTEMPTS WERE MADE WITH THE MANUAL METHOD. TWO IDS WERE USED, AND THERE WERE NO ISSUES WITH EITHER. 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). ANCILLARY DEVICES INCLUDE A 6F ENVOY GUIDE CATHETER AND SL-10 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712843 ↗
• MalfunctionApr 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AN AXIUM PRIME COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED SACCULAR ANEURYSM OF AN ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 5MM AND THE NECK DIAMETER WAS 2.8MM. BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT AFTER THE MICROCATHETER WAS IN PLACE DURING THE SURGERY, THE COIL WAS FORMED INTO A HOOP IN THE TUMOR CAVITY. DURING THE PROCESS, THE COIL WAS AUTOMATICALLY DETACHED WHEN IT HADN'T COMPLETELY ENTERED THE TUMOR CAVITY. AFTER IT WAS CLEAR THAT THE COIL WAS DETACHED ON ITS OWN, THE MICROCATHETER WAS WITHDRAWN, AND THE TAIL OF THE COIL WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A SOLITAIRE AB STENT WAS USED TO SUCCESSFULLY CAPTURE THE COIL OUTSIDE THE BODY. THE MAIN BRANCHES OF THE LEFT INTERNAL CAROTID ARTERY ANGIOGRAPHY WERE CLEARLY SHOWN, AND THERE WAS NO THROMBOSIS. THE MICROCATHETER WAS GUIDED BY THE GUIDEWIRE INTO THE TUMOR CAVITY TO CONTINUE THE EMBOLIZATION OPERATION. THE SURGERY WAS SUCCESSFULLY COMPLETED, AND THE PATIENT HAD NO ADVERSE REACTIONS AFTER THE SURGERY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO KINK/DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11708365 ↗
• MalfunctionMar 25, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE AN AXIUM PRIME COIL PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANTERIOR COMMUNICATING ANEURYSM. IT WAS REPORTED THAT AFTER THE MICROCATHETER WAS IN PLACE DURING THE SURGERY, THE COIL WAS FORMED INTO A HOOP IN THE TUMOR CAVITY. DURING THE PROCESS, THE COIL WAS AUTOMATICALLY DETACHED WHEN IT HADN'T COMPLETELY ENTERED THE TUMOR CAVITY. AFTER IT WAS CLEAR THAT THE COIL WAS DETACHED ON ITS OWN, THE MICROCATHETER WAS WITHDRAWN, AND THE TAIL OF THE COIL WAS LOCATED IN THE INTERNAL CAROTID ARTERY. A SOLITAIRE AB STENT WAS USED TO SUCCESSFULLY CAPTURE THE COIL OUTSIDE THE BODY. THE MAIN BRANCHES OF THE LEFT INTERNAL CAROTID ARTERY ANGIOGRAPHY WERE CLEARLY SHOWN, AND THERE WAS NO THROMBOSIS. THE MICROCATHETER WAS GUIDED BY THE GUIDEWIRE INTO THE TUMOR CAVITY TO CONTINUE THE EMBOLIZATION OPERATION. THE SURGERY WAS SUCCESSFULLY COMPLETED, AND THE PATIENT HAD NO ADVERSE REACTIONS AFTER THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573003 ↗
• MalfunctionJul 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE PHYSICIAN REPOSITIONED THE AXIUM COIL ONE TIME, IT AUTOMATICALLY DETACHED. THE COIL REMAINED IMPLANTED AT THE IMPLANTED LOCATION, AND SO THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO DAMAGE WAS OBSERVED TO THE PUSHWIRE, AND IT WAS DISCARDED. THERE WAS NO FRICTION DURING DELIVERY, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. 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, RUPTURED ANEURYSM OF THE ANTERIOR COMMUNICATING (ACOM) ARTERY WITH A MAX DIAMETER OF 5.7MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. ANCILLARY DEVICES INCLUDE A 6FR MERIT MEDICAL, CHAPERON 6FR, ECHELON 10 MICROCATHETER, CHIKAI 014.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10333284 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab