Concerto Detachable Coil System NV-7-30-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536044968), received between Dec 5, 2022 and Aug 24, 2026 — classified as 1 death, 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Break; Separation Failure; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410847 ↗
• MalfunctionAug 11, 2026Physical Resistance/Sticking

  Medtronic received a report that a Concerto coil did not advance and was stuck in the middle of the catheter. There was no damage to the coil or catheter. The product was replaced with a Medtronic product to complete the procedure. No patient symptoms or complications were associated with this event. It was unknown what condition was being treated. It was noted the patient's blood flow was normal and vessel tortuosity was moderate. The reported device and any accessory devices were prepared as indicated in the instructions for use (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204513 ↗
• MalfunctionFeb 20, 2026Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL NON-DETACHMENT. IT WAS REPORTED THAT THE CONCERTO COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). AN INSTANT DETACHER WAS NOT USED. THE COIL WOULD NOT DETACH DESPITE THREE ATTEMPTS TO DETACH MANUALLY WITH THE HYPOTUBE. THE COIL WAS WITHDRAWN AND REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402992 ↗
• MalfunctionOct 29, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL WAS BLOCKED AND BROKEN BEFORE DELIVERY. IT WAS NOTED THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT WHO WAS UNDERGOING GONADIC VEIN EMBOLIZATION. THE LESION LENGTH WAS 30MM. THERE WERE NO A BNORMALITIES REPORTED IN RELATION TO THE PATIENT'S ANATOMY. THERE WAS NO NOTED TORTUOSITY OF THE VESSEL, NOR ANY VESSEL CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417227 ↗
• MalfunctionJul 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT CONCERTO COIL STUCK AND ENCOUNTERED RESISTANCE AT THE CATHETER MIDDLE SECTION. IT WAS UNKNOWN IF THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE CATHETER USED WAS NOT A MEDTRONIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640106 ↗
• MalfunctionMar 24, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  2025-JAN-17 E2 (REP, FOR): NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679134 ↗
• MalfunctionAug 9, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT A COIL FAILED TO DETACH. IT WAS REPORTED THAT THE COIL DID NOT DEPLOY. THE PHYSICIAN COULD NOT RECALL IF THEY USED ID OR MANUAL DEPLOYMENT AT THE HBI AND IT WAS UNKNOWN HOW MANY DETACHMENT ATTEMPTS WERE MADE. AN ADDITIONAL COIL WAS USED INSTEAD. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19948711 ↗
• MalfunctionApr 25, 2024Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size; Unintended Movement; Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size; Unintended Movement

  MEDTRONIC RECEIVED A REPORT THAT DIFFICULT PLACEMENT OCCURRED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE COILS WOULD NOT FORM AND CONTINUED TO BE STRAIGHT. THERE WAS NO SHAPE TO THE COIL. IT CONTINUED MIGRATING INTO THE VESSEL. THE REPORTED DEVICES AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A GUIDE CATHETER AND MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19185625 ↗
• DeathJun 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ADDITIONAL INFORMATION RECEIVED REPORTED THE MEDTRONIC SPONSOR ASSESSMENT OF THE EVENT WAS UPDATED/CORRECTED TO INDICATE THAT THE EVENT OF SUBDURAL HEMATOMA AND RELATED OUTCOME WERE NOT RELATED TO THE PROCEDURE OR THE CONCERTO COILS. THIS EVENT IS NO LONGER REPORTABLE. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDR'S ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THE EVENT REPORTABLE.

  Patient problems: Convulsion/Seizure; Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17175118 ↗
• InjuryJan 23, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT REGARDING TWO CONCERTO COILS THAT FAILED TO DETACH. THE PATIENT WAS UNDERGOING GASTRODUODENAL ARTERY (GDA) TREATMENT. IT WAS REPORTED THAT THESE ARE THE 2 HELIX COILS THAT WE HAD ISSUES WITH. INEVITABLY THEY WERE BOTH DEPLOYED AND IMPLANTED IN THE PATIENT. AS WELL AS CHARGED TO THE PATIENT OF COURSE. THE COILS WERE PLACEDIN THE GDA WITH A NON-TORTUOUS APPROACH. THE REBAR 18 WAS THE MICROCATHETER BEING USED. AT THE CLOSE OF THE CASE IT WAS NOTED THAT THE INTERNAL RELEASE WIRE REMAINED ATTACHED TO THE COIL AND PARTIALLY WITHIN THE AORTA. THE TECHS NOTED THAT THE CASE SEEMED TO GO AS NORMAL UNTIL THEY HAD ISSUES WITH THE 2 - 7 X 30 HELICAL COILS. THEY DID PLACE A NUMBER OF OTHER COILS WITHOUT DIFFICULTY. IT WAS REPORTED THAT NON-DETACHMENT OCCURRED. IT IS NOT STATED HOW MANY TIMES THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER. THE PHYSICIAN DID TRY TO DETACH WITH ANOTHER INSTANT DETACHER, BUT IT IS UNKNOWN HOW MANY TIMES THE SECOND INSTANT DETACHER WAS USED. IT IS UNKNOWN IF THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. IT WAS REPORTED THERE WAS NO ISSUE WITH THE INSTANT DETACHER.  THE REPORTED DEVICE AND ANY ACCESSORY DEVICE

  Patient problems: Foreign Body In Patient

  MAUDE report 16223942 ↗
• MalfunctionDec 5, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURE. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT SEVERAL DETACHMENT ATTEMPTS WERE MADE WITH BOTH THE INSTANT DETACHER (ID) AND THE MANUAL METHOD. A SECONDING ID WAS NOT USED, AND THERE WERE NO ISSUES WITH THE ID. THE COIL WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. OTHER COILS WERE USED SUCCESSFULLY WITH THE CATHETER. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915268 ↗