AxiumTM PC-2-8-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536032989), received between Sep 9, 2020 and Aug 7, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 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.

• 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 NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476649 ↗
• 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 MICROCATHETER. IT WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476427 ↗
• 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 NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476404 ↗
• 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 17416811 ↗
• MalfunctionOct 15, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO THE COIL NON-DETACHMENT. EACH COIL WAS ATTEMPTED TO BE DETACHED WITH THE MANUAL METHOD 2-3 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639705 ↗
• MalfunctionOct 15, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO THE COIL NON-DETACHMENT. EACH COIL WAS ATTEMPTED TO BE DETACHED WITH THE MANUAL METHOD 2-3 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639680 ↗
• MalfunctionSep 9, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE IN THE SHEATH WITH THE AXIUM COILS. THE COIL WOULD NOT ADVANCE INTO THE CATHETER AND WAS REPLACED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A NON-MEDTRONIC MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10507245 ↗

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