ConcertoTM NV-10-30-HELIX (UDI 00847536033610)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847536033610), received between Jan 13, 2021 and Oct 25, 2023 — classified as 5 malfunctions.

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

• MalfunctionOct 25, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL CAN'T BE DETACHED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE 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 18006029 ↗
• MalfunctionSep 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DETACHED BY ITSELF FROM THE WIRE. A SNARE WAS USED TO REMOVE THE COIL, AND A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351273 ↗
• MalfunctionApr 13, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS UNABLE TO BE DETACHED WITH THE INSTANT DETACHER AND THE MANUAL DETACHMENT METHOD. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU WITHOUT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14092724 ↗
• MalfunctionDec 2, 2021Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE FELT DURING DELIVERY AND THE COIL WAS BROKEN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM IN THE SUBCARINAL VASCULAR LOCATION WITH AN UNKNOWN MAX DIAMETER AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DOCTORS FOUND A PIECE OF BROKEN COIL WIRE WHEN THEY REMOVED THE INTRODUCER SHEATH FROM THE FEMORAL ARTERY AFTER COMPLETING THE PROCEDURE. SO THEY ARRANGED THE PATIENT TO DO ANOTHER CT SCAN AND THEY FOUND THAT THE COIL WIRE/FILAMENT WAS BROKEN AND RETAINED IN THE PATIENT. IT WAS DECIDED TO CUT DOWN THE GROIN AND ATTEMPT TO USE A SNARE AND REMOVE THE COIL FILAMENT. AFTER A FEW ATTEMPTS, PART OF THE COIL FILAMENT WAS REMOVED AND BROKEN INTO THREE PIECES. THERE WAS A SHORT SEGMENT OF THE COIL FILAMENT THAT COULD NOT BE REMOVED AND REMAINED IN THE PATIENT'S BODY. THE PATIENT'S CONDITION WAS FINE AND THERE WAS NO FURTHER TREATMENT NEEDED AT THE MOMENT. IT WAS THOUGHT THAT THE COIL FILAMENT WAS MAYBE DUE TO A PREMATURE DETACHMENT OF THE COIL DURING DELIVERY. THERE WAS STRONG RESISTANCE FELT DURING DELIVERY AND THE C

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12915959 ↗
• MalfunctionJan 13, 2021Break; Break

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167150 ↗