Axium Prime Detachable Coil SystemRecalls & reported problems across all models

We found 70 models of Axium Prime Detachable Coil System by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 497 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2021 and Sep 28, 2026 — classified as 5 deaths, 23 injuries, 469 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (200 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Axium Prime Detachable Coil System problems

Axium Prime Detachable Coil System models

70 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Axium Prime Detachable Coil System APB-2-4-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 deaths35 reports
• Axium Prime Detachable Coil System APB-1.5-2-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  24 reports
• Axium Prime Detachable Coil System APB-3-6-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  23 reports
• Axium Prime Detachable Coil System APB-2-8-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  22 reports
• Axium Prime Detachable Coil System APB-1.5-3-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  21 reports
• Axium Prime Detachable Coil System APB-1-1-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  21 reports
• Axium Prime Detachable Coil System APB-2-6-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  21 reports
• Axium Prime Detachable Coil System APB-1-2-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  19 reports
• Axium Prime Detachable Coil System APB-3-8-3D-ES

  Device, Vascular, for Promoting Embolization
  19 reports
• Axium Prime Detachable Coil System APB-2.5-4-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  15 reports
• Axium Prime Detachable Coil System APB-1-2-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  15 reports
• Axium Prime Detachable Coil System APB-2-4-HX-ES

  Device, Vascular, for Promoting Embolization
  14 reports
• Axium Prime Detachable Coil System APB-2.5-6-3D-ES

  Device, Vascular, for Promoting Embolization
  13 reports
• Axium Prime Detachable Coil System APB-1.5-3-HX-ES

  Device, Vascular, for Promoting Embolization
  13 reports
• Axium Prime Detachable Coil System APB-4-12-3D-SS

  Device, Vascular, for Promoting Embolization
  1 death13 reports
• Axium Prime Detachable Coil System APB-1.5-4-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  12 reports
• Axium Prime Detachable Coil System APB-2-3-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  11 reports
• Axium Prime Detachable Coil System APB-3-4-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  10 reports
• Axium Prime Detachable Coil System APB-1.5-2-HX-ES

  Device, Vascular, for Promoting Embolization
  10 reports
• Axium Prime Detachable Coil System APB-1-3-3D-ES

  Device, Vascular, for Promoting Embolization
  9 reports
• Axium Prime Detachable Coil System APB-1-4-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• Axium Prime Detachable Coil System APB-5-15-3D-SS

  Device, Vascular, for Promoting Embolization
  9 reports
• Axium Prime Detachable Coil System APB-1-3-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Axium Prime Detachable Coil System APB-1.5-4-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Axium Prime Detachable Coil System APB-6-20-3D-SS

  Device, Vascular, for Promoting Embolization
  8 reports
• Axium Prime Detachable Coil System APB-2-2-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• Axium Prime Detachable Coil System APB-3.5-8-3D-ES

  Device, Vascular, for Promoting Embolization
  7 reports
• Axium Prime Detachable Coil System APB-3-8-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death7 reports
• Axium Prime Detachable Coil System APB-3-6-HX-ES

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium Prime Detachable Coil System APB-6-15-3D-SS

  Device, Vascular, for Promoting Embolization
  6 reports
• Axium Prime Detachable Coil System APB-2-3-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  5 reports
• Axium Prime Detachable Coil System APB-4-10-3D-SS

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium Prime Detachable Coil System APB-4-12-HX-SS

  Device, Vascular, for Promoting Embolization
  5 reports
• Axium Prime Detachable Coil System APB-4-10-HX-SS

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium Prime Detachable Coil System APB-5-15-HX-SS

  Device, Vascular, for Promoting Embolization
  4 reports
• Axium Prime Detachable Coil System APB-3.5-6-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium Prime Detachable Coil System APB-2-2-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium Prime Detachable Coil System APB-3-4-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium Prime Detachable Coil System APB-3-10-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Axium Prime Detachable Coil System APB-4-8-3D-SS

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium Prime Detachable Coil System APB-4-6-HX-SS

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium Prime Detachable Coil System APB-5-20-HX-SS

  Device, Vascular, for Promoting Embolization
  3 reports
• Axium Prime Detachable Coil System APB-3.5-10-3D-ES

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Prime Detachable Coil System APB-2.5-6-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Axium™ Prime Detachable Coil System APB-2.5-6-HX-ES

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium™ Prime Detachable Coil System FC-3-6-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium™ Prime Detachable Coil System FC-7-20-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Prime Detachable Coil System APB-4-6-3D-SS

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Prime Detachable Coil System APB-5-10-3D-SS

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Prime Detachable Coil System APB-5-10-HX-SS

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Prime Detachable Coil System APB-6-20-HX-SS

  Device, Vascular, for Promoting Embolization
  2 reports
• Axium Prime Detachable Coil System FC-3.5-8-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  2 reports
• Axium Prime Detachable Coil System APB-1.5-1-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium Prime Detachable Coil System APB-2.5-4-HX-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium™ Prime Detachable Coil System APB-3-6-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium™ Prime Detachable Coil System APB-3-8-3D-ES

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium™ Prime Detachable Coil System APB-5-15-3D-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium™ Prime Detachable Coil System APB-2-8-HX-ES

  Device, Vascular, for Promoting Embolization
  1 report
• Axium™ Prime Detachable Coil System FC-5-15-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium™ Prime Detachable Coil System FC-10-30-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium™ Prime Detachable Coil System FC-10-40-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Prime Detachable Coil System APB-6-10-3D-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Prime Detachable Coil System APB-4-8-HX-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Prime Detachable Coil System APB-6-12-HX-SS

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Prime Detachable Coil System FC-3-6-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium Prime Detachable Coil System FC-3-8-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium Prime Detachable Coil System FC-4-8-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Prime Detachable Coil System FC-5-20-3D

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Axium Prime Detachable Coil System FC-6-10-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Axium Prime Detachable Coil System FC-8-20-3D

  Device, Vascular, for Promoting Embolization
  1 report

Recent Axium Prime Detachable Coil System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923740 ↗
• MalfunctionSep 28, 2026Separation Failure; Physical Resistance/Sticking

  Medtronic received a report that an Axium coil encountered resistance in the Echelon catheter and failed to deploy. The Echelon catheter was also found kinked. The patient was undergoing aneurysm embolization for treatment of a saccular, unruptured aneurysm located in the C6 segment with a max diameter of 3.69 mm and a 3.45 mm neck diameter. The accessed vessel was the femoral artery with a diameter of 6.5 mm. It was noted the patient's blood flow was normal, and vessel tortuosity was normal. It was reported that during the aneurysm procedure, when using the Echelon to deliver the Axium coil, the resistance was obvious during advancement. Upon continuing to push, after it was advanced into position with difficulty, the coil could not be deployed normally. The operator suspected an Echelon issue. After removing the Echelon, it was found that the tip end had kinked and could not be used. After replacing with a new Echelon, coil advancement was smooth; however, after reaching the target position, it still could not be detached. Subsequently, a new coil was used instead; advancement was smooth and all were successfully deployed. The reported device and any accessory devices were prepar

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915621 ↗
• MalfunctionSep 24, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892345 ↗
• MalfunctionSep 24, 2026Unintended Movement; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886464 ↗
• MalfunctionSep 24, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884578 ↗
• MalfunctionSep 24, 2026Separation Failure; Detachment of Device or Device Component; Material Deformation

  Medtronic received a report of a Axium coil that had prematurely detached from non-detachment with the backup method. The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm located in the middle cerebral artery bifurcation section with a max diameter of 5mm and a 2.4mm neck diameter. It was noted the patient's blood flow was normal, and the vessel tortuosity was normal. No images are available for review. It was reported that when using the coil involved in this event, after coil deployment was completed, detachment was attempted using the backup detachment method. After breaking the backup detachment point and pulling out the detachment wire, it was found that the coil had not separated from the delivery wire. The delivery wire was repeatedly advanced and withdrawn, but the coil still could not be detached. Torque was applied, and the delivery wire was repeatedly rotated 360 degrees, but it still could not be detached. The operator then attempted to withdraw the entire coil into the microcatheter. While withdrawing it into the microcatheter, the coil detached. The operator believed that the coil detachment point was abnormal and requested factory inspect

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50882692 ↗
• MalfunctionSep 23, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872675 ↗
• MalfunctionSep 23, 2026Detachment of Device or Device Component

  Medtronic received a report that the doctor pushed the Axium coil into Headway microcatheter, and then the coil auto detach in microcatheter. It was unknown if the reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this event.    Ancillary devices include a Chikai10 Guidewire.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868423 ↗
• MalfunctionSep 23, 2026Separation Failure; Detachment of Device or Device Component; Migration; Physical Resistance/Sticking

  Medtronic received a report of Axium coil detachment after non-detachment. The patient was undergoing surgery for treatment of a saccular, ruptured "comunicante" anterior aneurysm with a max diameter of 4 mm and a 3 mmneck diameter. It was noted the patient's blood flow was normal and vessel tortuosity was moderate. The reported event occurred during normal use, i.e during the life of an implanted device; after post-op and before explant. It was reported that at the time of release of the device, the Axium coil detached erratically, causing a part of it to prolapse into the left anterior cerebral artery. As a result of this event, a thrombosis of the compromised vessel occurred, generating an intraprocedural complication. As a rescue measure, a stent was implanted in order to restore blood circulation and maintain vascular permeability. The coil was stuck in the sheath and had non-detachment. The physician attempted to detach the coil with the Instant Detacher three times. The physician did not try to detach with another Instant Detacher. There was one manual method at detachment attempted via hypotube. There was no issue with the Instant Detacher. The device and any accessories we

  Patient problems: Thrombosis/Thrombus

  MAUDE report 50867752 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525667 ↗
• MalfunctionAug 17, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286712 ↗
• MalfunctionAug 17, 2026Detachment of Device or Device Component

  Medtronic received a report that an Axium coil prematurely detached. The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm of the M2 Bifurcation Sinistra with a max diameter of 8mm and a 4mm neck diameter. It was noted the patient's blood flow was normal and vessel tortuosity was minimal. It was reported that the coil remains in the patient body. It was unknown if the coil was implanted at the intended location. Patient is alive and in good condition. No surgical or medicinal intervention was required. The pushwire was not bent or broken. There was no friction or difficulty during delivery. The physician did not reposition the coil or attempt to detach the coil. The physician did not rotate the delivery pusher during procedure. A continuous flush was administered during the procedure. The reported device and any accessory devices were prepared as indicated in the instructions for use (IFU). No patient symptoms or complications were associated with this event. Ancillary devices include an Avigo guidewire and Echelon microcatheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50272946 ↗
• MalfunctionAug 13, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237610 ↗
• MalfunctionAug 12, 2026Stretched; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222819 ↗
• MalfunctionAug 12, 2026Separation Failure; Physical Resistance/Sticking

  Medtronic received a report that Axium coils encountered resistance and non-detachment. The patient was undergoing aneurysm embolization surgery for treatment of a saccular, unruptured aneurysm located on the ophthalmic artery with a max diameter of 5mm and a 2.7mm neck diameter. The access vessel was the femoral artery with a 6mm vessel diameter. It was noted the patient's blood flow was normal and vessel tortuosity was moderate. It was reported that during the aneurysm embolization procedure, significant resistance occurred during coil delivery at the distal section of the Echelon catheter. The QC-2-6-3D  coil could not be pushed out of the protective sheath. Both the coil and microcatheter were removed and replaced. Additionally, when the APB-1-3-3D-ES S coil was delivered, it could not be detached after reaching the target position. The physician attempted to detach with the instant detacher 1. The also attempted 1 time with the second instant detacher. A manual attempt via hypo tube was attempted 2 times. The coil was withdrawn and replaced.  The catheter was flushed and all devices were prepared as indicated in the IFU. No patient complications were associated with this event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222684 ↗

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