AxiumTM PC-2-6-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536032972), received between Feb 21, 2022 and Aug 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DOCTOR WAS EMBOLIZING A BILATERAL MIDDLE MENINGEAL ARTERY (MMA) FOR A SUBDURAL BLEED AND POST PARTICLE INJECTION INTO THE MMA DECIDED TO FOLLOW-UP WITH AXIUM COILS TO EMBOLIZE, BUT MOST OF THE REQUESTED COILS DESIRED WERE ON BACKORDER FROM MEDTRONIC. THE DOCTOR THEN USED A MIX OF BOTH STRYKER COILS AND MEDTRONIC AXIUM COILS. AN ECHELON 10 MICROCATHETER ( REF# (B)(4). LOT# B540757) WAS INSERTED FOR EMBOLIZING WITH BOTH PARTICLES AND COILS INTO THE MMA BRANCHES. ALL COILS WERE PREPPED AND HYDRATED PER THE IFU IN A BOWL OF HEPARINIZED SALINE AND RETRACTED BACK INTO THE COILING SHEATH AS THE COILING SHEATH WAS HELD IN A VERTICAL MANNER. DUE TO THE NON-TAPERED AXIUM PGLA COIL SHEATH LEAVING A SMALL GAP BETWEEN THE COILING SHEATH AND ECHELON 10 HUB, THE COIL AS ADVANCED ¿BREAKS¿ AT THE DISTAL COILING SHEATH CAUSING HEAVY RESISTANCE AND THE COIL IS UNABLE TO EXIT THE COILING SHEATH. A NEW COIL IS REQUESTED, BUT ALL FOUR COILS IN THIS REPORT ALL EXPERIENCED THE SAME FAILURE AND THE DISTAL SECTION OF THE COILING SHEATH DUE TO THE SAME HEAVY RESISTANCE AS THE COILS WERE IN THE PROCESS OF TRANSFERRING FROM THE COILING SHEATH TO THE MICROCA THETER. IT WAS N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476395 ↗
• MalfunctionJul 28, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE APPEARED TO BE NO DAMAGE TO THE PUSHWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17416775 ↗
• MalfunctionFeb 21, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS COIL NON-DETACHMENT. SINCE THE DEVICE COULD NOT BE DEPLOYED DURING THE OPERATION, THE OPERATION WAS PERFORMED AGAIN WITH THE REPLACEMENT OF SPARE PARTS. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER MORE THAN 3 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER INSTANT DETACHER. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE, MORE THAN 3 TIMES.  THERE WAS NO ISSUE WITH THE INSTANT DETACHER. 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.   THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED ANEURYSM IN THE ANTERIOR COMMUNICATING ARTERY WITH A MAX DIAMETER OF 4.5MM AND A 2.5MM 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 13573128 ↗

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-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
• 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