ConcertoTM PV-16-40-HELIX (UDI 00847536033665)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536033665), received between Oct 6, 2020 and May 4, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 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, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THE COIL WAS BEING USED AS PER THE IFU, BUT IT COULD NOT BE DETACHED EITHER INSTANT DETACHER NOR MANUAL METHOD. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769939 ↗
• InjuryMar 5, 2021Positioning Problem; Migration; Positioning Problem; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT RECEIVE ANY ANTIPLATELET REGIMEN.

  Patient problems: Aneurysm

  MAUDE report 11424080 ↗
• InjuryMar 5, 2021Positioning Problem; Migration; Positioning Problem; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT REVIEW OF THE CASE WITH THE VASCULAR SURGEON AND INTERVENTIONAL RADIOLOGIST FOUND THAT THERE WAS NO MIGRATION OF ANY OF THE COILS. THEY WERE PLACED AS THE PHYSICIAN POSITIONED THEM DURING THE PROCEDURE TO ADDRESS THE RUPTURED ANEURYSM. HOWEVER, THE PHYSICIAN POSITIONED THE COILING "TOO DOWNSTREAM," RESULTING IN COLLATERAL FEEDERS STILL PROVIDING FLOW INTO THE ANEURYSM SAC. THE RADIOLOGIST CLOSED THE ENDOLEAK WITH ONYX INJECTION.

  Patient problems: Aneurysm

  MAUDE report 11424078 ↗
• MalfunctionOct 6, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROVIDER (HCP) WROTE "DEFECTIVE - WON'T DEPLOY" ON THE OUTSIDE OF THE AXIUM COIL BOX. IT WAS BELIEVED THE COIL WOULD NOT DETACH, BUT THE MANUFACTURING REPRESENTATIVE (REP) DID NOT HAVE A CLEAR UNDERSTANDING OF WHAT HAPPENED. THERE WAS NO INJURY TO THE PATIENT WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SPLENIC SAC EMBOLIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10634594 ↗