Concerto Detachable Coil System NV-3-4-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00847536044890), received between Nov 30, 2022 and Sep 25, 2026 — classified as 1 death, 32 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (15 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Physical Resistance/Sticking

  Medtronic received a report that a coil could not be advanced. All devices were prepared as indicated in the IFU and no patient symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898765 ↗
• MalfunctionAug 7, 2026Physical Resistance/Sticking

  Medtronic received a report that the Concerto coil could not be advanced. The procedure was completed by using a new product, and the causes or contributing factors for the coil not advancing were not identified. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50183554 ↗
• MalfunctionJul 27, 2026Separation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035985 ↗
• MalfunctionJun 24, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT DURING REPRESENTATIVE FOLLOW-UP REGARDING A MISSING ITEM. UPON REVIEW OF THE USAGE LOG, A PRODUCT STICKER WAS IDENTIFIED WITH ¿FAULTY¿ WRITTEN NEXT TO IT. A NURSE WAS CONSULTED AND RECALLED THAT THE SURGEON EXPERIENCED DIFFICULTY DETACHING THE DEVICE AFTER THE CONCERTO COIL HAD BEEN FORMED. THE SURGEON ATTEMPTED MANUAL DETACHMENT BY BENDING THE DISTAL END OF THE DELIVERY SYSTEM 90 DEGREES UPWARD AND 90 DEGREES DOWNWARD. NO INSTANT DETACHER WAS USED. WHEN DETACHMENT WAS UNSUCCESSFUL, THE COIL WAS RECAPTURED, DISCARDED, AND A DIFFERENT COIL WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN WHETHER ANY ADDITIONAL DETACHMENT ATTEMPTS WERE MADE VIA THE HYPOTUBE. THE INSTANT DETACHER WILL NOT BE RETURNED FOR INVESTIGATION, AS NO ISSUE WITH THE INSTANT DETACHER WAS REPORTED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608771 ↗
• MalfunctionMar 24, 2026Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL COULD NOT BE DEPLOYED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT A CONCERTO COIL (LOT # 227008043) COULD NOT BE DEPLOYED WITH THE INSTANT DETACHER, THE CUSTOMER REFUSED TO DEPLOY MANUALLY. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 2 TIMES, THE PHYSICIAN DID NOT TRY TO DETACH WITH ANOTHER DETACHER. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THERE WAS NO MANUAL ATTEMPT AT DETACHMENT VIA HYPOTUBE. IT WAS REPORTED FOR A SECOND CONCERTO COIL (LOT # 230140611) USED THAT THE PUSHWIRE DISTAL SEGMENT WAS BENT AFTER OPENING THE PACKAGE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A DIREXION 0.021IN X 130CM MICROCATHETER. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE LONG BLACK PART OF THE COIL PUSHER WAS INSERTED INTO DETACHER AND PULLED BACK THE BUTTON, WHEN NOTHING HAPPENED. THERE WAS NO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24680049 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE CONCERTO COIL DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE COIL WAS REMOVED 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 24608201 ↗
• MalfunctionFeb 19, 2026Separation Failure

  ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT "FRAME" REFERRED TO THE PACKAGING HOOP. THE DAMAGE WAS NOT NOTICED UPON OPENING THE PACKAGE; IT WAS NOTICED WHEN THEY STARTED TO FEED THE COIL DOWN THE MICROCATHETER. IT WAS PREVIOUSLY REPORTED THAT THE DEVICES WERE PREPPED PER IFU WITHOUT ISSUE, WHICH WOULD HAVE OCCURRED PRIOR TO INTRODUCING THE COIL INTO THE MICROCATHETER. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING NOTED. TWO MANUAL ATTEMPTS WERE MADE TO DETACH THE NV-3-4-HELIX COIL. IT IS BELIEVED AN INSTANT DETACHER WAS NOT USED. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. NO PUSHWIRE DAMAGE WAS OBSERVED AFTER REMOVAL FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393640 ↗
• MalfunctionFeb 11, 2026Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED CLARIFICATION THAT THE COIL DETACHED PREMATURELY WITHIN THE NON-MEDTRONIC MICROCATHETER. IT WAS NOTED THAT CONTINUOUS FLUSH WAS NOT USED DURING THE PROCEDURE. ANCILLARY DEVICE: PROGREAT 2.4 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24313933 ↗
• MalfunctionFeb 3, 2026Detachment of Device or Device Component; Packaging Problem

  ADDITIONAL INFORMATION RECEIVED. THE INCIDENT OCCURRED BEFORE THE DEVICE WAS PREPARED AND DID NOT INVOLVE THE PATIENT. UPON OPENING THE PACKAGING, THE COIL WAS FOUND TO BE PRE-DEPLOYED WITHIN THE DELIVERY MICROCATHETER AND WAS IMMEDIATELY DISCARDED WITHOUT USE. VESSEL TORTUOSITY WAS MINIMAL. THE PROCEDURE WAS NOT COMPLETED WITH THIS DEVICE, AND IT WAS NOT REPLACED WITH ANOTHER PRODUCT. THE CAUSE OF THE PREMATURE DETACHMENT WAS NOT DETERMINED. THE COIL HAD PREMATURELY DETACHED IN THE DELIVERY MICROCATHETER THAT COMES WITH THE DEVICE, WITH NO OTHER CATHETERS OR ACCESSORIES INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24248820 ↗
• MalfunctionJan 21, 2026Separation Failure

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE OBSERVED TOT THE CONCERTO COIL. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO NON-DETACHMENT. THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24132047 ↗
• MalfunctionSep 11, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DOCTOR WAS FAMILIAR WITH CONCERTO COILS AND HAD USED THEM BEFORE. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU). IT WAS CLARIFIED THAT THE COIL COULD NOT BE PUSHED OUT OF THE WHITE PROTECTIVE SHEATH DESPITE 8-10 ATTEMPTS. THEREFORE THE COIL WAS REPLACED TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028162 ↗
• MalfunctionJul 17, 2025Break; Separation Failure; Detachment of Device or Device Component; Break; Separation Failure; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT JUST A PART OF THE COIL WAS DETACHED FROM THE LAUNCHER. THE REST REMAINED ATTACHED TO THE LAUNCHER. THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT.  THE COIL REMAINS IN THE PATIENT. THE COIL WAS IMPLANTED AT THE INTENDED LOCATION. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534755 ↗
• MalfunctionJun 19, 2025Inadequacy of Device Shape and/or Size; Material Deformation; Inadequacy of Device Shape and/or Size; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE PRODUCT WAS BEING USED PER THE IFU, BUT THE COIL WAS KINKED WITHIN THE MICROCATHETER AND FAILED TO FORM ITS INTENDED HELICAL SHAPE. A NEW MEDTRONIC PRODUCT WAS USED TO COMPLETE THE PROCEDURE. 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 WAS RECEIVED STATING THAT THE CAUSE OF THE KINK AND SHAPE ISSUE WAS NOT DETERMINED. THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294386 ↗
• MalfunctionMay 29, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A CONCERTO COIL WAS BEING USED AS PER THE IFU BUT THE COIL DID NOT PASS THROUGH THE MICROCATHETER THAT WAS USED IN THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 WAS RECEIVED STATING THAT THE CAUSE AND LOCATION OF RESISTANCE COULD NOT BE REMEMBERED. THE PHYSICIAN ALSO COULD NOT REMEMBER IF THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO KINK/DAMAGE TO THE COIL AND CATHETER AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22111497 ↗
• MalfunctionMar 25, 2025Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS SEPARATED. 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 21690035 ↗
• MalfunctionMar 19, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE COIL CONCERTO HELIX 4MM X 10CM AND COIL CONCERTO HELIX 3MM X 4CM, THERE WAS A NON-DETACHMENT ISSUE WITH BOTH COILS. THE DEVICES WERE NOT PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE, SPECIFICALLY LACKING CONTINUOUS FLUSH. MANUAL ATTEMPTS AT DETACHMENT VIA HYPOTUBE WERE MADE TWICE FOR EACH COIL, BUT DETACHMENT FAILED. ONE INSTANT DETACHER WAS USED AND WAS DISCARDED, THUS NOT RETURNED FOR INVESTIGATION. TWO ATTEMPTS WERE MADE TO DETACH WITH THE INSTANT DETACHER FOR THE COIL CONCERTO HELIX 3MM X 4CM. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE PATIENT WAS ALIVE WITH NO INJURY REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649301 ↗
• MalfunctionJan 16, 2025Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE COIL CONCERTO HELIX 3MM X 4CM AND COIL CONCERTO HELIX 3MM X 8CM, THERE WERE ISSUES WITH COIL RESISTANCE AND NON-DETACHMENT. THE COILS WERE STUCK IN THE MICROCATHETER AND COULD NOT BE DEPLOYED WITH THE DETACHER. HOWEVER, WHEN USED WITH A REBAR, THE COILS WERE SUCCESSFULLY DEPLOYED WITH THE DETACHER. THE MICROCATHETER USED WAS A BOSTON SCIENTIFIC RENEGADE HI-FLO. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL THREE TIMES WITH THE INSTANT DETACHER, BUT NO MANUAL ATTEMPT VIA HYPOTUBE WAS MADE. THE INSTANT DETACHER WAS DISCARDED AND NOT RETURNED FOR INVESTIGATION. THE PATIENT EXPERIENCED NO SYMPTOMS OR COMPLICATIONS, AND THE OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21171628 ↗
• MalfunctionNov 20, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT FOUR CONCERTO COILS FAILED TO DEPLOY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED NO PATIENT WAS INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736572 ↗
• MalfunctionNov 20, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT 6 CONCERTO COILS FAILED TO DEPLOY. THE DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO PATIENT WAS INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736565 ↗
• MalfunctionAug 21, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WOULD NOT BE ADVANCED. 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 20011168 ↗
• MalfunctionAug 12, 2024Material Deformation; Packaging Problem; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE TECH OPENED THE PACKAGE AND SAID THAT THE DETACHMENT END WAS BENT IN THE PUSHWIRE PROXIMAL SEGMENT. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. THE CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED REPORTED ADDITIONAL INFORMATION RECEIVED REPORT THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19963641 ↗
• MalfunctionJul 17, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING PROCEDURE, THE CONCERTO COIL COULD NOT ENTER THE MICROCATHETER. THE TIP OF THE COIL WAS BENT. IT WAS REPORTED THERE WAS COIL KINK/DAMAGE. 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 19763630 ↗
• MalfunctionMar 14, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL (LOT # 227265617, 227307378, 227097384, 227484440, 226765268, 227220849) WOULD NOT DEPLOY. IT WAS REPORTED CONCERTO COIL (LOT # 227265615) WAS STUCK IN THE MICROCATHETER. IT WAS REPORTED CONCERTO COIL (LOT # 227396350) COILED UP BEFORE IT DEPLOYED. IT WAS REPORTED CONCERTO COIL (LOT # 227529311) WAS DEFECTIVE. 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 18906213 ↗
• MalfunctionMar 14, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE "COIL IS NOT PUSHED". THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904428 ↗
• MalfunctionFeb 13, 2024Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN REPOSITIONING THE COIL, IT CANNOT BE PUSHED. THE COIL WAS KINKED/DAMAGED. THERE WAS FRICTION DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGE WAS LOCATED ON THE PUSHWIRE PROXIMAL SEGMENT. THE PHYSICIAN REPOSITIONED THE COIL DURING THE PROCEDURE 2 TIMES. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR ENDOLEAK TREATMENT. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS HIGH AND VESSEL TORTUOSITY WAS NORMAL. ANCILLARY DEVICES INCLUDE A RENEGADE MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT CATHETER RESISTANCE OCCURRED IN THE PROXIMAL SECTION. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693880 ↗

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