ConcertoTM NV-5-15-HELIX (UDI 00847536033559)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536033559), received between Jul 24, 2020 and Feb 6, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL HAD NO LOOP FORMATION DURING THE PROCEDURE. THE CONCERTO COIL AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651737 ↗
• MalfunctionMar 14, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542584 ↗
• MalfunctionDec 15, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH WITH BOTH METHODS. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015096 ↗
• MalfunctionOct 5, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER THE REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576640 ↗
• MalfunctionApr 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE OBSERVED TO THE COIL PUSHWIRE OR THE INSTANT DETACHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703561 ↗
• MalfunctionMar 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE PROCESS OF FOLLOWING THE IFU, COIL DETACHMENT OCCURRED BEFORE THE PHYSICIAN DETACHED IT INTENTIONALLY. THE PATIENT WAS UNDERGOING SURGERY TO TREAT AN ANEURYSM OF THE ILIAC ARTERY - COMMON. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11557890 ↗
• MalfunctionJul 24, 2020Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE UNRAVELED AT THE PROXIMAL END FROM THE DELIVERY WIRE. THE PATIENT WAS DOING WELL, AND THERE WAS NO IMPACT NOTED AT POST PROCEDURE IMAGING THE NEXT DAY. IT WAS REPORTED THAT THE PATIENT HAD STENOSIS IN THE VESSELS PRIOR TO THE PROCEDURE, AND SHORT TERM PHARMACEUTICAL MANAGEMENT ADDRESSED THE SPASM. THE PATIENT WAS BEING TREATED FOR GASTRODUODENAL ARTERY EMBOLIZATION. THE VESSEL WAS 4-5 MM.

  Patient problems: Vasoconstriction

  MAUDE report 10320134 ↗