ConcertoTM NV-8-30-HELIX (UDI 00847536033597)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536033597), received between Jan 6, 2021 and May 21, 2024 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL PUSHWIRE WAS BENT AT THE PROXIMAL END THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED RENAL ARTERY ANEURYSM WITH A SACCULAR MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 7 MM, NECK DIAMETER 5 MM. THE PATIENT¿S VESSEL TORTUOSITY AND BLOOD FLOW WAS NORMAL. THERE WAS FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE PROCEDURE WAS COMPLETED BY USING A ANOTHER CONCERTO COIL. THE WIRE WAS BENT WHEN IT WAS OPENED. THERE WERE ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND, IT WAS STATED THERE WAS AN INFLUENCE OF THE OPERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19363489 ↗
• MalfunctionSep 12, 2022Unintended Movement; Unintended Movement

  MEDTRONIC RECEIVED INFORMATION THAT 3 CONCERTO COILS HAD COMPACTION. OCCURRED ACCORDING TO THIS FOLLOW UP FORM. ASSESSMENT ABOUT RELATEDNESS. NO ADVERSE EVENT OR DEVICE DEFICIENCY REPORTED. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407752 ↗
• MalfunctionSep 12, 2022Unintended Movement; Unintended Movement

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LESION TREATED IN INDEX PROCEDURE: ARTERIAL-FEMORAL. THERE WAS ANGIOGRAM POST INDEX PROCEDURE ON (B)(6) 2021 WITH THE OUTCOME: SUCCESSFUL OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15407748 ↗
• MalfunctionMar 29, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DID NOT DETACH. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL DID NOT DETACH FROM ITS WIRE (BOTH MANUAL AND DETACHER METHODS WERE TRIED SEVERAL TIMES). A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945734 ↗
• MalfunctionJul 14, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE OBSERVED ON THE PUSHWIRE. THE CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166373 ↗
• MalfunctionJun 3, 2021Break; Migration; Break; Migration

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IF THE PHYSICIAN INDICATED THAT IF COIL REMAINS WHERE IT IS, IT SHOULD NOT BE AN ISSUE UNLESS IT MIGRATES FURTHER. THE SURGEON WHO PERFORMED THE PROCEDURE CONSULTED WITH THE LEAD VASCULAR SURGEON AND INFORMED THE VASCULAR SURGEON OF THE MIGRATED COIL AFTER THE COMPLETED THE EMBOLIZATION PROCEDURE. THE LEAD SURGEON COMMENTED THAT THE DESIRED EMBOLIZATION RESULT IS SHOWN FROM THE REDUCED FLOW IN THE HYPOGASTRIC ARTERIES. THE COIL WAS IMPLANTED AND DETACHED AT THE INTENDED LOCATION BUT MIGRATED SLIGHTLY AFTERWARDS. POST-PROCEDURE ANGIOGRAPHY SHOWED IT HAD MIGRATED DISTALLY. THE COIL SEEMED TO BE IN THE SAME LOCATION AFTER STENT IMPLANTATION OVER THE COMMON ILIAC COVERING THE INTERNAL ILIAC. NO ADDITIONAL INTERVENTION WAS NOTED TO BE NECESSARY. THERE WAS NO VISIBLE DAMAGE OBSERVED TO THE COIL PUSHWIRE. HANDLING OF THE COIL WAS VERY CAREFUL AND IT WAS MAINTAINED AS STRAIGHT AS POSSIBLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930403 ↗
• MalfunctionApr 27, 2021Separation Failure; Material Deformation; Physical Resistance/Sticking; Separation Failure; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THE COIL THAT FAILED TO DETACH WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND A REPLACEMENT CONCERTO COIL WAS USED TO COMPLETE THE PROCEDURE. THE INSTANT DETACHER WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732092 ↗
• MalfunctionJan 6, 2021Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE FOLLOWING INFORMATION WAS UNKNOWN: WHETHER PREMATURE DETACHMENT OR NON-DETACHMENT OCCURRED, HOW MANY DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER OR MANUAL METHOD, IF THERE WERE ANY ISSUES ENCOUNTERED PRIOR TO NON-DETACHMENT, IF THERE WAS ANY DAMAGE TO THE PUSHWIRE, IF THE COIL WAS IMPLANTED OR REMOVED FROM THE PATIENT, AND LESION CHARACTERISTICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11124157 ↗