ConcertoTM NV-5-20-HELIX (UDI 00847536033566)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00847536033566), received between Apr 22, 2020 and Feb 7, 2024 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2024Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking; Inadequacy of Device Shape and/or Size; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DOESN'T FORM LOOPS AND WON'T COME OUT OF THE SHEATH. 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 18660663 ↗
• MalfunctionMar 15, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED AS PER THE INSTRUCTIONS FOR USE (IFU). THE COIL GOT STUCK WITHIN THE MICROCATHETER AND COULD NOT PASS THROUGH IT. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NEW INFORMATION WAS RECEIVED. IT IS UNKNOWN WHERE IN THE CATHETER WAS THE RESISTANCE. IT IS UNKNOWN IF THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. IT IS UNKNOWN IF THERE WAS ANY KINK/DAMAGE TO THE COIL OBSERVED AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16546430 ↗
• MalfunctionJun 5, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL DID NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 5 TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599696 ↗
• MalfunctionJun 1, 2022Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS STUCK IN THE MICROCATHETER. IT WAS REPORTED THAT THIS WAS A COMPLICATED CASE. THE PATIENT WAS BLEEDING OUT DUE TO A LOWER GI BLEED AND IT WAS SAID TO BE A "BIG MESS." ABDOMINAL ANGIO WAS CLEAN BUT VENOUS EXTRAVASATION WAS SEEN IN THE ASCENDING COLON. THEY ENDED UP GOING TRANSHEPATIC TO GET INTO THE VEIN AND ENDED UP USING 12 CONCERTOS AND A GELFOAM SLURRY IN THE PROCEDURE. IT WAS REPORTED THAT THE CONCERTO COIL WAS UNABLE TO BE DEPLOYED, BUT THEY MANAGED TO SUCCESSFULLY DEPLOY AN ADDITIONAL 12 CONCERTOS WITH THIS ONE IN THE MIDDLE OF THE MIX, RANGING FROM 8MM X 30 DOWN TO 4MM X 10CM. ALL COILS WERE DEPLOYED THROUGH THE 2.4FR PROGREAT MICROCATHETER AS INSTRUCTED, BUT THIS 5 X 20 WAS DIFFICULT TO PUSH (4 OTHER 5 X 20S WERE SUCCESSFULLY USED). ANOTHER COIL WAS USED IN THE SAME CATHETER, AND THERE WAS NO DAMAGE TO THE CATHETER. THE EVENT WAS SAID TO BE NOT ASSOCIATED WITH THE PATIENT. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY WERE ADVANCING THE COIL AND HAD REMOVED THE INTRODUCER SHEATH AND IT GOT STUCK INSIDE OF THE MICROCATHETER. IT WAS REPORTED THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566945 ↗
• InjuryOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THERE WERE TWO CASES OF COILS THAT ACHIEVED HEMOSTASIS AND THE PATIENTS CAME BACK ABOUT A WEEK LATER WITH FLOW THROUGH THE COIL PACK. ADDITIONAL INFORMATION RECEIVED REPORTED 3 CONCERTO COILS WERE INVOLVED IN THE EVENT. THE INITIAL EMBOLIZATION PROCEDURE WAS COMPLETED WITH (B)(6) 2021. FLOW THROUGH THE COILS WAS OBSERVED AND THE PATIENT WAS SYMPTOMATIC. A SECOND EMBOLIZATION PROCEDURE OF THE SAME ARTERY WAS COMPLETED (B)(6) 2021. NO IMAGES WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 12586205 ↗
• MalfunctionJul 15, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED NO DAMAGE WAS OBSERVED TO THE PUSHWIRE, AND THERE HAD BEEN NO ISSUES PRIOR TO THE NON-DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172889 ↗
• MalfunctionJun 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED NO MORE INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051928 ↗
• MalfunctionApr 15, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND THE PATIENT VESSEL WAS T ORTUOUS. IT WAS UNKNOWN HOW MANY DETACHMENT ATTEMPTS WERE MADE WITH THE INSTANT DETACHER OR MANUAL METHOD. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672411 ↗
• MalfunctionApr 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DETACHED PREMATURELY. THE COIL WAS IMPLANTED IN THE INTENDED LOCATION IN THE PATIENT, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN, THERE WAS NO FRICTION DURING DELIVERY, NO DETACHMENT ATTEMPTS HAD BEEN MADE, THE PUSHWIRE WAS NOT ROTATED DURING THE PROCEDURE, AND A CONTINUOUS FLUSH HAD BEEN ADMINISTERED. THE PATIENT'S VESSEL TORTUOSITY HAD BEEN MODERATE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602564 ↗
• MalfunctionMar 22, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING THREE CONCERTO COILS THAT HAD DIFFICULTY DETACHING WITH 2 DIFFERENT INSTANT DETACHERS AND STANDARD MANUAL METHOD/HYPOTUBE. IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE, THE FIRST CONCERTO COIL WAS IMPLANTED AND DETACHED NORMALLY. THE SECOND CONCERTO COIL WOULD NOT DETACH WITH THE INSTANT DETACHER (ID) SO MANUAL DETACHMENT WAS ATTEMPTED BUT WAS ALSO UNSUCCESSFUL. FINALLY, THE PHYSICIAN PULLED THE "STRING" IN ITS ENTIRETY AFTER WHICH TIME THE COIL WAS STILL ATTACHED AND ONLY DETACHED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT AND IT GOT BACK TO THE CATHETER AT WHICH TIME IT DETACHED. THE COIL WAS THEN ABLE TO BE IMPLANTED AT THE INTENDED LOCATION. THE RADIOLOGIC TECHNOLOGIST THOUGHT IT WAS POSSIBLE THE ID WAS THE PROBLEM AND A NEW ID WAS OPENED TO TRY WITH THE REMAINING 2 COILS. HOWEVER, THE NEW ID ALSO DID NOT WITH WITH THE LAST 2 COILS AND THEY WERE BOTH DETACHED USING THE SAME METHOD AS THE PREVIOUS COIL, PULLING BACK TO THE CATHETER. ALL THE COILS WERE ULTIMATELY IMPLANTED SUCCESSFULLY AT THE INTENDED LOCATION. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546603 ↗
• MalfunctionMar 22, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING THREE CONCERTO COILS THAT HAD DIFFICULTY DETACHING WITH 2 DIFFERENT INSTANT DETACHERS AND STANDARD MANUAL METHOD/HYPOTUBE. IT WAS REPORTED THAT DURING A SPLENIC EMBOLIZATION PROCEDURE, THE FIRST CONCERTO COIL WAS IMPLANTED AND DETACHED NORMALLY. THE SECOND CONCERTO COIL WOULD NOT DETACH WITH THE INSTANT DETACHER (ID) SO MANUAL DETACHMENT WAS ATTEMPTED BUT WAS ALSO UNSUCCESSFUL. FINALLY, THE PHYSICIAN PULLED THE "STRING" IN ITS ENTIRETY AFTER WHICH TIME THE COIL WAS STILL ATTACHED AND ONLY DETACHED WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT AND IT GOT BACK TO THE CATHETER AT WHICH TIME IT DETACHED. THE COIL WAS THEN ABLE TO BE IMPLANTED AT THE INTENDED LOCATION. THE RADIOLOGIC TECHNOLOGIST THOUGHT IT WAS POSSIBLE THE ID WAS THE PROBLEM AND A NEW ID WAS OPENED TO TRY WITH THE REMAINING 2 COILS. HOWEVER, THE NEW ID ALSO DID NOT WITH WITH THE LAST 2 COILS AND THEY WERE BOTH DETACHED USING THE SAME METHOD AS THE PREVIOUS COIL, PULLING BACK TO THE CATHETER. ALL THE COILS WERE ULTIMATELY IMPLANTED SUCCESSFULLY AT THE INTENDED LOCATION. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11546348 ↗
• MalfunctionJan 26, 2021Separation Failure; Separation Failure

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11229604 ↗
• MalfunctionJan 6, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL WHICH FAILED TO DETACH. THE PATIENT WAS UNDERGOING A PROCEDURE FOR COIL EMBOLIZATION OF A CAROTID-CAVERNOUS FISTULA (CCF). BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL WAS IN PLACE AND THE SURGEON AT TEMPTED TO DETACH THE COIL MANUALLY BUT DETACHMENT FAILED. TWO ATTEMPTS WERE MADE TO DETACH THE COIL MANUALLY WITHOUT SUCCESS. THERE WAS NO ATTEMPT MADE TO DETACH THE CONCERTO COIL WITH AN INSTANT DETACHER. THE COIL WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125190 ↗
• MalfunctionJul 27, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE PATIENT WAS BEING TREATED FOR A SPLENIC ANEURYSM, WHICH IS OFF-LABEL USE AS THE COIL ARE APPROVED FOR INTRACEREBRAL USE. THERE WAS NO KINK OR DAMAGE OBSERVED TO THE PUSHWIRE AFTER REMOVAL. OTHER CONCERTO COILS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 10328380 ↗
• MalfunctionJul 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED ALL OF THE OTHER CONCERTO COILS USED WERE FINE. THE DOCTOR HAD NOTICED THROUGH IMAGING THE COIL WAS DETACHED AND JUST BEING PUSHED WITH MORE FRICTION THROUGH. THE PROCEDURE WAS STOPPED AND THEY REMOVED THE CATHETER AND COIL. THE CATHETER USED WAS A PROGREAT 2.4 (TERUMO).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10313809 ↗
• MalfunctionApr 22, 2020Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT HAD RESISTANCE IN THE CATHETER AND THEN BROKE WHEN BEING RESHEATHED. THE DEVICE WAS PREPARED ACCORDING TO THE MANUFACTURER INSTRUCTIONS FOR USE. THE DEVICE WAS DISCARDED. IT WAS NOTED THAT OTHER CONCERTO COILS WERE ABLE TO BE PLACED BOTH BEFORE AND AFTER THE ISSUE OCCURRED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9986531 ↗