ConcertoTM NV-6-20-HELIX (UDI 00847536033573)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00847536033573), received between Feb 5, 2020 and Feb 14, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (7 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.

• MalfunctionFeb 14, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS NOT DETACHED SO ANOTHER CONCERTO COIL WAS USED. IT WAS REPORTED NONDETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER THREE TIMES. THE PHYSICIAN DID TRY TO DETACH WITH ANOTHER INSTANT DETACHER THREE TIMES. THERE WAS A MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE TWO TIMES. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES 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 16372864 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DETACHED PREMATURELY. THE PATIENT WAS BEING TREATED FOR A GASTROINTESTINAL BLEED. PATIENT BLOOD FLOW AND VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL SELF DEPLOYED. IT WAS STILL IN THE SHEATH AND REMOVED FROM THE PATIENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO FRICTION OR DIFFICULTY DURING DEPLOYMENT. THE PHYSICIAN DID NOT REPOSITION THE COIL. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079459 ↗
• MalfunctionJan 7, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING 2 CONCERTO COILS THAT HAD RESISTANCE AND A PUSHER WAS DAMAGED AND A THIRD COIL THAT WOULDN'T DETACH. THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL COILS AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE 4X8 AND 5X20 COILS HAD RESISTANCE IN THE MIDDLE SECTION OF THE MICROCATHETER AND ACCORDIONED. THE 5X20 COIL HAD DAMAGE TO THE DISTAL END OF THE PUSHER BUT NO DAMAGE WAS NOTED TO THE 4X8 COIL. CONTINUOUS FLUSH WAS NOT USED BUT BUT THE PHYSICIAN FLUSHED THE CATHETER BEFORE LOADING EACH COIL, BUT THE COILS COULD NOT TRACK THROUGH THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE 6X20 COIL COULD NOT BE DETACHED. MANUAL DETACHMENT WAS ATTEMPTED TWICE WITHOUT SUCCESS; THERE WAS NO ATTEMPT TO DETACH THE COIL WITH AN INSTANT DETACHER. ANOTHER MANUFACTURER'S PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: TERUMO PROGREAT 2.8 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196666 ↗
• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2021 MPXR 843210 (REP, HCP, FOR, DIS): MEDTRONIC RECEIVED A REPORT THAT THE DURING PREPARATION IT WAS FOUND THAT THE COIL WAS ALREADY SEPARATED FROM ITS WIRE BEFORE BEING INSERTED INTO PATIENT BODY. A NEW MEDTRONIC 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 11940205 ↗
• 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 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 11546165 ↗
• MalfunctionNov 30, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REPORTING A CONCERTO COIL FAILED TO DEPLOY. ANOTHER CONCERTO COIL FAILED TO DEPLOY AND FRACTURED. THE PROCEDURE WAS TO TREAT AN ENDOLEAK. 6 OTHER CONCERTO COILS WERE IMPLANTED SUCCESSFULLY TO COMPLETE THE PROCEDURE. ANCILLARY DEVICE: 2.8 FR PROGREAT CATHETER REFER TO MANUFACTURER REPORT 2029214-2020-01168 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10923528 ↗
• MalfunctionNov 24, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THE CONCERTO COIL WAS STUCK IN THE HUB OF THE MICROCATHETER. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE EVENT. IT WAS REPORTED THE CONCERTO COIL WAS STUCK IN THE INTRODUCER SHEATH. NO MORE INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897716 ↗
• MalfunctionNov 24, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED PER THE INSTRUCTIONS FOR USE (IFU), BUT THE COIL DID NOT DETACH AFTER USING THE INSTANT DETACHER AND THE MANUAL DETACHMENT METHOD. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897647 ↗
• MalfunctionNov 23, 2020Break; Separation Failure; Break; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REPORTING A CONCERTO COIL FAILED TO DEPLOY AND FRACTURED. THE PROCEDURE WAS TO TREAT AN ENDOLEAK. 6 CONCERTO COILS WERE IMPLANTED SUCCESSFULLY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10888985 ↗
• MalfunctionSep 24, 2020Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED INDICATED THE COIL WAS REMOVED FROM THE PATIENT, AND THEY RECOVERED FROM THE PROCEDURE SUCCESSFULLY WITH NO ADVERSE EVENTS. THE OPERATOR HAD EXPERIENCED DIFFICULTY WHILE ADVANCING THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10584309 ↗
• MalfunctionFeb 5, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CONCERTO COIL WAS PLACED IN THE CAVITY, AND THE HEALTHCARE PROVIDER (HCP) WAS UNABLE TO RELEASE THE COIL. BOTH THE HANDLE AND THE MANUAL DETACHMENT METHODS WERE UNSUCCESSFUL. A NEW COIL WAS USED AND PLACED WITH NO PROBLEMS. 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 Known Impact Or Consequence To Patient

  MAUDE report 9673357 ↗