Concerto Detachable Coil SystemRecalls & reported problems across all models

We found 34 models of Concerto Detachable Coil System by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 595 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2022 and Sep 30, 2026 — classified as 21 deaths, 31 injuries, 543 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (260 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 Concerto Detachable Coil System problems

Concerto Detachable Coil System models

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

• Concerto Detachable Coil System NV-3-8-HELIX

  Device, Vascular, for Promoting Embolization
  81 reports
• Concerto Detachable Coil System NV-2-8-HELIX

  Device, Vascular, for Promoting Embolization
  79 reports
• Concerto Detachable Coil System NV-2-6-HELIX

  Device, Vascular, for Promoting Embolization
  4 deaths71 reports
• Concerto Detachable Coil System NV-2-4-HELIX

  Device, Vascular, for Promoting Embolization
  2 deaths46 reports
• Concerto Detachable Coil System NV-6-20-HELIX

  Device, Vascular, for Promoting Embolization
  35 reports
• Concerto Detachable Coil System NV-3-4-HELIX

  Device, Vascular, for Promoting Embolization
  1 death33 reports
• Concerto Detachable Coil System NV-5-20-HELIX

  Device, Vascular, for Promoting Embolization
  1 death31 reports
• Concerto Detachable Coil System NV-8-30-HELIX

  Device, Vascular, for Promoting Embolization
  2 deaths29 reports
• Concerto Detachable Coil System NV-4-10-HELIX

  Device, Vascular, for Promoting Embolization
  2 deaths28 reports
• Concerto Detachable Coil System PV-20-50-HELIX

  Device, Vascular, for Promoting Embolization
  21 reports
• Concerto Detachable Coil System NV-5-15-HELIX

  Device, Vascular, for Promoting Embolization
  5 deaths19 reports
• Concerto Detachable Coil System NV-10-30-HELIX

  Device, Vascular, for Promoting Embolization
  2 deaths18 reports
• Concerto Detachable Coil System NV-4-8-HELIX

  Device, Vascular, for Promoting Embolization
  12 reports
• Concerto Detachable Coil System NV-7-30-HELIX

  Device, Vascular, for Promoting Embolization
  1 death11 reports
• Concerto Detachable Coil System PV-3-8-3D

  Device, Vascular, for Promoting Embolization
  11 reports
• Concerto Detachable Coil System PV-16-40-HELIX

  Device, Vascular, for Promoting Embolization
  10 reports
• Concerto Detachable Coil System PV-18-40-HELIX

  Device, Vascular, for Promoting Embolization
  9 reports
• Concerto Detachable Coil System PV-12-40-3D

  Device, Vascular, for Promoting Embolization
  8 reports
• Concerto Detachable Coil System PV-12-30-HELIX

  Device, Vascular, for Promoting Embolization
  6 reports
• Concerto Detachable Coil System PV-8-30-3D

  Device, Vascular, for Promoting Embolization
  6 reports
• Concerto Detachable Coil System PV-6-20-3D

  Device, Vascular, for Promoting Embolization
  5 reports
• Concerto Detachable Coil System NV-9-30-HELIX

  Device, Vascular, for Promoting Embolization
  1 death4 reports
• Concerto Detachable Coil System PV-14-30-HELIX

  Device, Vascular, for Promoting Embolization
  3 reports
• Concerto Detachable Coil System PV-3-6-3D

  Device, Vascular, for Promoting Embolization
  3 reports
• Concerto Detachable Coil System PV-2-2-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Concerto Detachable Coil System PV-2-4-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Concerto Detachable Coil System PV-2-6-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Concerto Detachable Coil System PV-5-15-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Concerto Detachable Coil System PV-14-40-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Concerto Detachable Coil System PV-16-40-3D

  Device, Vascular, for Promoting Embolization
  2 reports
• Concerto Detachable Coil System PV-7-30-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Concerto Detachable Coil System PV-9-30-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Concerto Detachable Coil System PV-10-30-3D

  Device, Vascular, for Promoting Embolization
  1 report
• Concerto Detachable Coil System PV-18-40-3D

  Device, Vascular, for Promoting Embolization
  1 report

Recent Concerto 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 30, 2026Physical Resistance/Sticking

  Medtronic received a report about a delivery wire getting stuck during in an instant detacher. The coil deployed successfully and no patient complications were associated with this event. Additional information was received reporting that the patient was undergoing treatment for an aortopulmonary collateral. The patient vessel tortuosity was moderate. No causes or contributing factors for the resistance were identified. The information has been confirmed/provided by the physician.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947629 ↗
• MalfunctionSep 29, 2026Material Deformation; Physical Resistance/Sticking

  Medtronic received information regarding two Concerto coils that had resistance during delivery and were damaged. The patient was undergoing an internal iliac artery embolization procedure. Patient's blood flow was normal and vessel tortuosity was severe. It was reported that the Concerto coils and all accessory devices were prepared as indicated in the instructions for use (IFU) with no friction or other issue noted. Continuous catheter flush was not administered during the procedure. During delivery, the coils experienced resistance during attempted delivery. Both coils became damaged, taking a "spring-like" shape due to the excessive force required to push them. Damage to the middle segment of the pushwire was noted. It was additionally noted that the physician did not reposition the coil at any time during the procedure. It was additionally noted that there was no friction or other difficulty during device testing or delivery despite report that excessive force was required to push them. There was no harm or injury to the patient associated with this event. Additional information was received clarifying that, excessive force was required while pushing the coils. It is unknown w

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927449 ↗
• MalfunctionSep 28, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923062 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922516 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50919760 ↗
• MalfunctionSep 28, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918404 ↗
• MalfunctionSep 28, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918257 ↗
• MalfunctionSep 25, 2026Material Deformation; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906181 ↗
• MalfunctionSep 25, 2026Physical Resistance/Sticking

  Medtronic received a report that a coil could not be advanced. All devices were prepared as indicated in the IFU and no patient symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898765 ↗
• MalfunctionSep 25, 2026Incomplete or Missing Packaging; Material Deformation; Packaging Problem

  Medtronic received a report that the product was damaged upon opening the package. The assumption was that it was damaged during man ufacturing. It was noted that the patients' blood flow was normal and vessel tortuosity was moderate. All devices were prepared as indicated in the IFU and no patient complications were associated with this event. Additional information received reported the pusher wire was not secured in the black rubber stopper when the package was opened. There was no damage to the box or internal packaging. There was identified cause or contributing factor for the out-of-package damage to the Concerto coil device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898568 ↗
• MalfunctionSep 23, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875993 ↗
• MalfunctionSep 18, 2026Positioning Failure; Failure to Advance

  Doctor tried to deploy the Concerto detachable coil system for a splenic bleed but there was too much resistance so he could not do so. No harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817930 ↗
• MalfunctionSep 8, 2026Difficult or Delayed Positioning; Material Deformation; Unintended Movement; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50677894 ↗
• MalfunctionSep 1, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542699 ↗
• MalfunctionAug 26, 2026Separation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453963 ↗

Other Micro Therapeutics, Inc. products

• PipelineTM Flex Embolization Device with Shield TechnologyTM79 models · 1,020 reports
• AxiumTM139 models · 832 reports · 1 recall
• PIPELINE114 models · 622 reports · 1 recall
• Axium Prime Detachable Coil System70 models · 497 reports
• ConcertoTM70 models · 436 reports
• EchelonTM5 models · 225 reports · 2 recalls
• Axium Detachable Coil System69 models · 288 reports
• Axium PrimeTM66 models · 237 reports