ConcertoTM NV-5-20-HELIX (UDI 00847536013520)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536013520), received between Nov 14, 2018 and Jun 4, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS BEING USED AS PER THE IFU; HOWEVER, THE COIL DID NOT DETACH FROM ITS WIRE WITH EITHER THE INSTANT DETACHER OR MANUAL METHOD. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11940084 ↗
• MalfunctionOct 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DISCONNECTED FROM THE CONNECTOR. IT WAS CONFIRMED THAT THE ISSUE OCCURRED INVOLUNTARILY. THE PATIENT WAS UNDERGOING AN EMBOLECTOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10731933 ↗
• MalfunctionSep 11, 2020Connection Problem

  DURING USE, THE COIL DISCONNECTED FROM THE "CONNECTOR" - THE USER DID NOT DISCONNECT IT, IT DID IT ON ITS OWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10520713 ↗
• MalfunctionMay 26, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), CLARIFIED THE COIL WOULD NOT DETACH INSIDE THE VESSEL. MEDTRONIC PRODUCTS WERE THEN USED TO COMPLETE THE PROCEDURE WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10089405 ↗
• MalfunctionNov 14, 2018Separation Failure; Separation Failure

  MEDTRONIC RECEIVED REPORT THAT DURING AN ANEURYSM COILING PROCEDURE, THE CONCERTO COIL DID NOT DETACH. THE DEVICE WAS REPLACED. NO PATIENT INJURY OCCURRED. THE DEVICE WAS USED AND PREPARED PER THE INSTRUCTIONS FOR USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8070713 ↗