Concerto Detachable Coil System NV-5-15-HELIXRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847536044937), received between Jan 18, 2023 and Aug 21, 2026 — classified as 5 deaths, 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Break; Difficult or Delayed Positioning; Use of Device Problem; Detachment of Device or Device Component; Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50373266 ↗
• MalfunctionMar 19, 2026Break; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT TWO 20 MM CONCERTO COILS WOULD NOT DETACH DUE TO FILAMENT BREAK, AND ONE 15 MM CONCERTO COIL WOULD NOT DETACH WHEN IT BROKE AT ITS END. THE PATIENT WAS TREATMENT FOR A GASTROINTESTINAL BLEED. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE TWO 20MM CONCERTO COILS WOULD NOT DETACH BECAUSE THE FILAMENT IN THE DETACHMENT FILAMENT BROKE AT HYPO TUBE BREAK INDICATOR WHEN ATTEMPTING TO MANUALLY DETACH THE COILS. THERE WAS NOT ENOUGH FILAMENT EXPOSED TO MANUALLY PULL TO DETACH THE COILS. THE COILS WERE REMOVED WITHOUT COMPLICATION AND NO RESISTANCE OCCURRED IN THE NON-MEDTRONIC CATHETER DURING DELIVERY OR POSITIONING. THE CONCERTO COIL 15MM COIL WOULD NOT DETACH MANUALLY. THIS PHYSICIAN/ACCOUNT TYPICALLY DOES NOT USE THE INSTANT DETACHER. THEY PREFER TO MANUALLY DETACH COILS. AFTER THESE THREE COILS DID NOT DEPLOY SUCCESSFULLY, THEY WENT ON TO USE SEVERAL MORE CONCERTO COILS WITHOUT COMPLICATIONS. THE PHYSICIAN DID NOT ATTEMPT TO DETACH USING ANY INSTANT DETACHER. INSTEAD, THERE WAS A SINGLE MANUAL ATTEMPT AT DETACHMENT. PRIOR TO COIL NON-DETACHMENT, NO ISSUES WERE ENCOUNTERED. NO PUSH WIRE DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640274 ↗
• MalfunctionJul 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL ENCOUNTERED RESISTANCE AND STUCK 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 PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. THE COIL HAD COME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22534814 ↗
• MalfunctionAug 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL WAS BEING USED AS PER THE IFU BUT THE COIL COULD NOT PASS THROUGH THE MICROCATHETER. A NEW MEDTRONIC PRODUCT 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 FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THERE WAS NO KINK/DAMAGE TO THE COIL AFTER REMOVAL. THE CATHETER WAS NOT A MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006094 ↗
• MalfunctionJul 1, 2024Break; Packaging Problem; Break; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE PACKAGE WAS OPENED, IT WAS DISCOVERED THAT THE PUSHER WAS KINKED/BROKEN IN THE DISTAL SEGMENT. THERE WAS NO FRICTION OR DIFFICULTY DURING TESTING OR DELIVERY. CONTINUOUS FLUSH WAS ADMINISTERED DURING 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.  ANCILLARY DEVICES INCLUDE A PROGREAT 2.4 MICROCATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT CLARIFIED THAT PART OF THE PUSHWIRE FRACTURED AND SEPARATED FROM THE REST. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE PROXIMAL END OF THE PUSHWIRE WAS SECURED IN THE GUIDEWIRE CLIP WHEN THE PACKAGE WAS OPENED. THERE WAS NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645316 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD 6 CONCERTO COILS IMPLANTED TO TREAT A 13MM SACCULAR ANEURYSM WITH VESSEL OCCLUSION COIL EMBOLIZATION ON (B)(6) 2022. ALL THE INVOLVED COILS WERE DELIVERED AND DEPLOYED SUCCESSFULLY TO ACHIEVE SUCCESSFUL TREATMENT OF THE TARGET VESSEL. NO DEVICE MALFUNCTION WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED ISCHEMIC CHOLECYSTITIS. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE EVENT RESOLVED WITH THE MEDICAL TREATMENT AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THE SITE AND STUDY SPONSOR ASSESSMENTS OF THE EVENT BOTH CONCLUDED THE EVENT WAS POSSIBLY/PROBABLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE CONCERTO DEVICES.

  Patient problems: Inflammation; Ischemia

  MAUDE report 19128500 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO HAD 6 CONCERTO COILS IMPLANTED TO TREAT A 13MM SACCULAR ANEURYSM WITH VESSEL OCCLUSION COIL EMBOLIZATION ON (B)(6) 2022. ALL THE INVOLVED COILS WERE DELIVERED AND DEPLOYED SUCCESSFULLY TO ACHIEVE SUCCESSFUL TREATMENT OF THE TARGET VESSEL. NO DEVICE MALFUNCTION WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED ISCHEMIC CHOLECYSTITIS. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT PROLONGED THE PATIENT'S HOSPITALIZATION. THE EVENT RESOLVED WITH THE MEDICAL TREATMENT AND THE PATIENT WAS DISCHARGED ON (B)(6) 2022. THE SITE AND STUDY SPONSOR ASSESSMENTS OF THE EVENT BOTH CONCLUDED THE EVENT WAS POSSIBLY/PROBABLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE CONCERTO DEVICES.

  Patient problems: Inflammation; Ischemia

  MAUDE report 19128322 ↗
• MalfunctionMar 14, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL LOOP NOT FORMED DURING PROCEDURE. 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 18900099 ↗
• MalfunctionFeb 21, 2024Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE HEALTHCARE PROVIDER (HCP) PERFORMED AN EMBOLIZATION AND HAD A FAULTY 5MM X 15CM COIL THAT THEY WERE UNABLE TO DEPLOY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18747958 ↗
• InjuryJan 23, 2024Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL PREMATURELY DETACHED IN THE CATHETER. DURING FLUOROSCOPY, UNKNOWN FOREIGN MATERIAL WAS FOUND IN THE PATIENT AND THE PHYSICIAN LEFT THE MATERIAL REMAINING IN THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY TO CLOSE VESSELS SUPPLYING BLOOD FLOW TO AN ENDOLEAK. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT UPON INITIALLY DEPLOYING THE CONCERTO COIL, THE PHYSICIAN PARTIALLY DEPLOYED THE COIL, BUT REALIZED HE WOULD LIKE A SHORTER LENGTH COIL. UPON RETRIEVAL OF THE COIL, THE COIL PREMATURELY DEPLOYED PARTIALLY INSIDE THE MICROCATHETER. THE PUSHER WIRE WAS RETRIEVED AND A SEPARATE WIRE WAS USED TO TRY AND PUSH THE REMAINING COIL OUT OF THE MICROCATHETER. THERE WAS RESISTANCE IN PUSHING THE WIRE INTO THE CATHETER SOMEWHERE IN THE MICROCATHETER. EVENTUALLY A 1CC SYRINGE WAS INJECTED INTO THE CATHETER TO PUSH THE REMAINING PART OF THE COIL OUT OF THE MICROCATHETER WHICH WAS SUCCESSFUL. THE WIRE WAS THEN SUCCESSFULLY RE-INTRODUCED INTO THE MICROCATHETER AND THE MICROCATHETER REPOSITIONED 2 ADDITIONAL 4X8MM CONCERTO COILS, WHICH WERE SUCCESSFULLY DELIVERED AND DEPLOYED. IT WAS ONLY AFTER THE SUCCESSFUL COMPLETIO

  Patient problems: Foreign Body In Patient

  MAUDE report 18566804 ↗
• MalfunctionDec 19, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN COULD NOT DETACH THE CONCERTO COIL. IT WAS REPORTED NON-DETACHMENT OCCURRED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL WITH THE INSTANT DETACHER 7-8 TIMES. THE PHYSICIAN DID NOT TRY TO DETACH THE COIL WITH ANOTHER INSTANT DETACHER. 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 18361513 ↗
• DeathAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT WAS NOT RELATED TO THE DEVICE OR THE THERAPY.

  Patient problems: Arrhythmia; Renal Failure; Respiratory Failure

  MAUDE report 17483741 ↗
• DeathAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT WAS NOT RELATED TO THE DEVICE OR THE THERAPY.

  Patient problems: Arrhythmia; Renal Failure; Respiratory Failure

  MAUDE report 17483737 ↗
• DeathJun 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION REGARDING 10 CONCERTO COILS THAT HAD COMPACTION DURING THE PROCEDURE. IN THE FOLLOWING WEEKS POST-OPERATIVE, THE PATIENT EXPERIENCED UNRELATED SUBDURAL HEMATOMA AND DIED. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A 1-2MM SACCULAR PSEUDOANEURYSM AND HEMORRHOIDS. IT WAS NOTED THAT THE 10 CONCERTO COILS WERE DELIVERED, DEPLOYED, AND DETACHED SUCCESSFULLY AS INTENDED. COIL COMPACTION WAS OBSERVED BUT NO REPORTED IMPACT TO THE PATIENT AT THE TIME OF THE PROCEDURE. ON (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL AND WAS NOTED TO HAVE AN ACUTE LEFT SUBDURAL HEMATOMA (SDH). THE PATIENT EXPERIENCED SEVERAL EPILEPTIC SEIZURES AND DIED, AS A RESULT, ON (B)(6) 2023. THE SITE ASSESSMENT OF THE EVENTS CONCLUDED THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR THE DEVICES. THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENTS WERE POSSIBLY RELATED TO THE PROCEDURE BUT NOT RELATED TO THE DEVICES. HOWEVER, THE INVESTIGATOR CONCLUSION AGREED WITH THE SITE ASSESSMENT THAT THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR DEVICES. ADDITIONAL INFORMATION RECEIVED REPORTED SINCE THIS ADVERSE EVENT OCCURRED 10

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

  MAUDE report 17175213 ↗
• DeathJun 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION REGARDING 10 CONCERTO COILS THAT HAD COMPACTION DURING THE PROCEDURE. IN THE FOLLOWING WEEKS POST-OPERATIVE, THE PATIENT EXPERIENCED UNRELATED SUBDURAL HEMATOMA AND DIED. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A 1-2MM SACCULAR PSEUDOANEURYSM AND HEMORRHOIDS. IT WAS NOTED THAT THE 10 CONCERTO COILS WERE DELIVERED, DEPLOYED, AND DETACHED SUCCESSFULLY AS INTENDED. COIL COMPACTION WAS OBSERVED BUT NO REPORTED IMPACT TO THE PATIENT AT THE TIME OF THE PROCEDURE. ON (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL AND WAS NOTED TO HAVE AN ACUTE LEFT SUBDURAL HEMATOMA (SDH). THE PATIENT EXPERIENCED SEVERAL EPILEPTIC SEIZURES AND DIED, AS A RESULT, ON (B)(6) 2023. THE SITE ASSESSMENT OF THE EVENTS CONCLUDED THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR THE DEVICES. THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENTS WERE POSSIBLY RELATED TO THE PROCEDURE BUT NOT RELATED TO THE DEVICES. HOWEVER, THE INVESTIGATOR CONCLUSION AGREED WITH THE SITE ASSESSMENT THAT THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR DEVICES. ADDITIONAL INFORMATION RECEIVED REPORTED SINCE THIS ADVERSE EVENT OCCURRED 10

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

  MAUDE report 17175197 ↗
• DeathJun 21, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION REGARDING 10 CONCERTO COILS THAT HAD COMPACTION DURING THE PROCEDURE. IN THE FOLLOWING WEEKS POST-OPERATIVE, THE PATIENT EXPERIENCED UNRELATED SUBDURAL HEMATOMA AND DIED. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE TO TREAT A 1-2MM SACCULAR PSEUDOANEURYSM AND HEMORRHOIDS. IT WAS NOTED THAT THE 10 CONCERTO COILS WERE DELIVERED, DEPLOYED, AND DETACHED SUCCESSFULLY AS INTENDED. COIL COMPACTION WAS OBSERVED BUT NO REPORTED IMPACT TO THE PATIENT AT THE TIME OF THE PROCEDURE. ON (B)(6) 2023, THE PATIENT RETURNED TO THE HOSPITAL AND WAS NOTED TO HAVE AN ACUTE LEFT SUBDURAL HEMATOMA (SDH). THE PATIENT EXPERIENCED SEVERAL EPILEPTIC SEIZURES AND DIED, AS A RESULT, ON (B)(6) 2023. THE SITE ASSESSMENT OF THE EVENTS CONCLUDED THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR THE DEVICES. THE MEDTRONIC STUDY SPONSOR ASSESSMENT CONCLUDED THE EVENTS WERE POSSIBLY RELATED TO THE PROCEDURE BUT NOT RELATED TO THE DEVICES. HOWEVER, THE INVESTIGATOR CONCLUSION AGREED WITH THE SITE ASSESSMENT THAT THE EVENTS WERE NOT RELATED TO THE PROCEDURE OR DEVICES. ADDITIONAL INFORMATION RECEIVED REPORTED SINCE THIS ADVERSE EVENT OCCURRED 10

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

  MAUDE report 17175108 ↗
• MalfunctionMay 17, 2023Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED THAT PRIOR TO COIL NON-DETACHMENT, THERE WERE NO ISSUES ENCOUNTERED. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. THE PATIENT'S WEIGHT AT THE TIME OF THE REPORTED EVENT IS UNKNOWN. IT IS UNKNOWN HOW MANY ATTEMPTS WERE MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THE INSTANT DETACHER LOT NUMBER IS UNKNOWN. IT IS UNKNOWN HOW MANY ATTEMPTS WERE MADE TO DETACH THE COIL USING THE MANUAL METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16947884 ↗
• MalfunctionJan 26, 2023Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL DID NOT DETACH. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16248874 ↗
• MalfunctionJan 18, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT REGARDING A CONCERTO COIL THAT HAD SEPARATED/BROKE/PREMATURE DETACHMENT OCCURRED.  IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS UNKNOWN. IT WAS REPORTED THAT THE CONCERTO COIL DEPLOYED IN THE MICROCATHETER. IT WAS REPORTED THAT COIL SEPARATION/BREAK/PREMATURE DETACHMENT OCCURRED. THE COIL WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE COIL WAS REMOVED. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION IT IS UNKNOWN IF THERE WAS ANY FRICTION OR DIFFICULTY DURING DELIVERY. IT IS UNKNOWN IF THE PHYSICIAN REPOSITIONED THE COIL. IT IS UNKNOWN IF THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. IT IS UNKNOWN IF THE PHYSICIAN ROTATED THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS NOT ADMINISTERED DURING THE PROCEDURE. 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 16194006 ↗