ConcertoTM NV-2-4-HELIX (UDI 00847536033481)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00847536033481), received between Jun 3, 2020 and Jan 5, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (12 reports).

2 other recalls cover devices cleared under the same FDA submission (K081465); they may or may not involve this specific model.

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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 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 LOOP FORMATION IS NOT POSSIBLE AND DOES NOT SLIP OUT OF SHEATH. 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 18453013 ↗
• MalfunctionDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL SPONTANEOUSLY DETACHED, DO NOT DETACH. IT WAS REPORTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. DURING PRE-OP, THE COIL PRE-DETACHED DURING PREPARATION. THERE WAS NO SURGICAL OR MEDICAL INTERVENTION REQUIRED. THE PUSHWIRE WAS NOT BENT OR BROKEN. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL.  THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING PROCEDURE. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT WAS INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15986225 ↗
• MalfunctionJul 26, 2022Separation Failure; Material Deformation; Separation Failure; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DETACH FROM THE PUSHER WIRE USING THE INSTANT DETACHER (ID). AT LEAST 3 OTHER CONCERTO COILS HAD BEEN SUCCESSFULLY DETACHED PRIOR TO THIS. ANOTHER 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. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15109014 ↗
• MalfunctionJul 7, 2022Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL WAS FOUND TO BE ALREADY DETACHED DURING PREPARATION PER IFU. AS THE ISSUE WAS OBSERVED DURING PREPARATION, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946543 ↗
• MalfunctionApr 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED BEFORE BEING USED ON A CASE. THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190112 ↗
• MalfunctionApr 13, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS UNABLE TO BE DETACHED. THE PRODUCT WAS BEING USED PER THE IFU, HOWEVER, BOTH THE MANUAL AND DETACHER METHOD WERE TRIED SEVERAL TIMES WITHOUT SUCCESS. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14109040 ↗
• MalfunctionApr 4, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT DURING THE PROCEDURE FOLLOWING IFU, COIL DETACHMENT WAS NOT MADE SUCCESSFULLY EVEN THOUGH THE PHYSICIAN TRIED BY DETACHER AND MANUALLY. A NEW CONCERTO COIL WAS USED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES 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 14001739 ↗
• MalfunctionSep 1, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES PRIOR TO THE COIL NON-DETACHMENT. NO DAMAGE WAS OBSERVED TO COIL PUSHWIRE WAS OBSERVED AFTER REMOVAL. ANY DAMAGE TO THE COIL CURRENTLY WAS CAUSED BY A MEDICAL STUDENT TRYING TO FORCE THE COIL BACK INTO ITS HOOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12407623 ↗
• MalfunctionAug 6, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DEPLOY. THERE WAS NO INJURY TO THE PATIENT REPORTED AS A RESULT OF THE EVENT, AND NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285947 ↗
• MalfunctionJul 21, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A COIL DETACHMENT ISSUE. WHEN BREAKING THE SHORT BLACK LINE AND THE COIL'S HYPOTUBE, THE FILAMENT BROKE ALSO SO THEY COULDN'T DETACH THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL WITH THE INSTANT DETACHER. THERE WAS ONE MANUAL ATTEMPT TO DETACH THE HYPOTUBE. IT WAS REPORTED THAT THE COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202675 ↗
• MalfunctionJul 8, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT FAILED TO DETACH. IT WAS REPORTED THAT THE CONCERTO COIL AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE COIL DID NOT DETACH WITH THE INSTANT DETACHER OR MANUAL METHOD EVENT AFTER SEVERAL ATTEMPTS. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER MEDTRONIC DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135004 ↗
• MalfunctionJul 8, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DETACH. BOTH THE MANUAL METHOD AND INSTANT DETACHER WERE USED SEVERAL TIMES. THE COIL WAS REPLACED, AND 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 12134937 ↗
• MalfunctionJul 8, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS DID NOT DETACH. BOTH THE MANUAL METHOD AND INSTANT DETACHER WERE USED SEVERAL TIMES. THE COILS WERE REPLACED, AND 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 12134829 ↗
• MalfunctionJul 8, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO CONCERTO COILS DID NOT DETACH. BOTH THE MANUAL METHOD AND INSTANT DETACHER WERE USED SEVERAL TIMES. THE COILS WERE REPLACED, AND 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 12134812 ↗
• MalfunctionJun 4, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION REGARDING A CONCERTO COIL THAT FAILED TO DETACH. IT WAS REPORTED THAT THE DEVICE WAS PREPARED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COIL DID NOT DETACH WITH THE INSTANT DETACHER OR MANUAL ATTEMPTS. THE COIL WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11941072 ↗
• MalfunctionMay 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE COIL WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATH. THE PATIENT WAS UNDERGOING SURGERY TO TREAT A GI BLEED. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INTRODUCER SHEATH WAS HELD AT A SLIGHT ANGLE WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852199 ↗
• MalfunctionMar 30, 2021Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Physical Resistance/Sticking; Difficult or Delayed Positioning; Therapy Delivered to Incorrect Body Area; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL BECAME STUCK AND DEPLOYED IN THE MICROCATHETER. IT WAS REPORTED THAT AFTER THE DOCTOR DEPLOYED SEVERAL COILS, THEY REPOSITIONED THE CATHETER TO ANOTHER SITE AND THE COIL THEN DEPLOYED IN THE CATHETER. THE COIL WAS STUCK IN THE CATHETER, AND THE DOCTOR SAID IT WAS DEFECTIVE. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A PROGREAT MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593235 ↗
• MalfunctionJan 6, 2021Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CUSTOMER BELIEVED THEY BROKE THE COIL EARLY IN THE WRONG PLACE. IT WAS CLARIFIED THAT THE PUSHWIRE BROKE, BUT THE CUSTOMER SAID THEY BENT IT. NO ATTEMPTS HAD BEEN MADE TO DETACH THE COIL, AND THE COIL WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11126087 ↗
• MalfunctionAug 11, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN LOADED THE 1ST COIL INTO THE MICROCATHETER AND ADVANCED THE COIL WITH NO RESISTANCE. THE PHYSICIAN USED FLUORO TO VISUALIZE THE COIL, BUT THERE WAS NO COIL ATTACHED TO THE PUSHER. THERE WAS ALSO NO EVIDENCE THAT THE COIL HAD INADVERTENTLY DETACHED NOR ANY VISUAL EVIDENCE OF A COIL AT ALL, JUST A VISUAL OF THE WIRE. THE COIL COULD NOT BE IDENTIFIED AS MIGRATED SOMEWHERE IN THE BODY. THE PHYSICIAN DID NOT PUSH OUT THE COIL PRIOR TO PLACING IT INTO THE MICROCATHETER SO UNSURE IF THERE WAS A COIL ATTACHED IN THE FIRST PLACE. THE PHYSICIAN REMOVED THE WIRE AND ATTEMPTED WITH A 2ND AND 3RD COIL; HOWEVER, NEITHER COIL WOULD ADVANCE INTO THE HUB OF THE MICROCATHETER. THE PHYSICIAN OPENED AND TRIED TO ADVANCE A 4TH COIL, BUT IT WAS STUCK IN THE CLEAR PLASTIC INTRODUCER. THE PHYSICIAN SWAPPED OUT THE MICROCATHETER WITH AN NEW ONE, AND THE NEW MICROCATHETER'S WIRE HAD NO PROBLEM ADVANCING AND TRACKING IN THE MICROCATHETER. THE PHYSICIAN TRIED TWO MORE COILS WITH THE NEW MICROCATHETER AND WAS ABLE TO COMPLETE THE EMBOLIZATION. THE PATIENT WAS UNDERGOING TREATMENT OF A PSEUDOANEURYSM. IT WAS NOTED THE VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10392093 ↗
• MalfunctionJun 3, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED IT WAS UNKNOWN HOW MANY DETACHMENT ATTEMPTS WERE MADE USING THE INSTANT DETACHER AND MANUAL METHODS. IT WAS UNKNOWN IF THERE WERE ANY ISSUES ENCOUNTERED PRIOR TO THE NON-DETACHMENT, AND UNKNOWN IF THERE WAS ANY PUSHWIRE DAMAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10115557 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081465. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-7-30-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular a
• Z-0873-2012 · Mar 1, 2010 · Terminated
  Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular ab