ConcertoTM NV-3-8-HELIX (UDI 00847536033528)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00847536033528), received between Oct 22, 2019 and Feb 2, 2024 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (17 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2024Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE CAUSE OF THE NON-DETACHMENT WAS NOT DETERMINED. PRIOR TO COIL NON-DETACHMENT, NO I SSUES WERE ENCOUNTERED. PROCEDURE AND COIL DELIVERY CONDITION WAS SAME IN NORMAL TIMES. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL FROM THE PATIENT. PUSHWIRE WAS IN NORMAL CONDITION. THE PROCEDURE WAS SUCCESSFULLY FINISHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18634813 ↗
• MalfunctionOct 25, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COIL WAS STUCK AT THE CATHETER HUB. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670531 ↗
• MalfunctionJul 19, 2022Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  MEDTRONIC RECEIVED INFORMATION THAT A REBAR CATHETER MARKER WAS NOT VISIBLE, THEREFORE THE CONCERTO COIL WAS MISPLACED AND FAILED PO SITIONING. THE COIL WAS NOT IMPLANTED AT THE INTENDED LOCATION. NO ADDITIONAL STEPS OR SURGICAL INTERVENTIONS REQUIRED TO REMOVE OR SECURE THE COIL. THE DEVICE DID NOT JUMP DURING DEPLOYMENT. THE VESSEL WAS NOT DAMAGED. THE TIP OF THE CATHETER WAS NOT UNDER STRESS. THE PHYSICIAN DID ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE ANEURYSM DID NOT RUPTURE. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. ACCESS TO THE VESSEL WAS INGUINAL. THE ACCESS VESSEL DIAMETER WAS 8MM. VESSEL TORTUOSITY WAS MODERATE. THE EVENT DID NOT LEAD TO OR EXTENT PATIENT HOSPITALIZATION. NO TREATMENT WAS GIVE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15060053 ↗
• MalfunctionJul 13, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COULD NOT BE DETACHED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL MANY TIMES. THE PHYSICIAN TRIED WITH A SECOND INSTANT DETACHER ONE TIME. THERE WAS NO ISSUE WITH THE INSTANT DETACHER. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). PATIENT BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MODERATE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009631 ↗
• MalfunctionMay 5, 2022Separation 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 ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THEY PHYSICIAN ATTEMPTED TO DETACH THE COIL 3 TIMES WITH THE FIRST INSTANT DETACHER (ID) AND THEN ATTEMPTED ANOTHER 3 TIMES WITH A DIFFERENT INSTANT DETACHER BUT THE COIL COULD NOT BE DETACHED. NO ATTEMPT WAS MADE TO DETACH THE COIL MANUALLY WITH THE HYPOTUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288801 ↗
• MalfunctionApr 12, 2022Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT THE AXIUM PRIME COIL WAS ALREADY DETACHED FROM ITS WIRE WHEN IT WAS FIRST OPENED. 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 14090519 ↗
• MalfunctionMar 31, 2022Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN TRIED TO DETACH THE CONCERTO COIL SEVERAL TIMES, BUT IT COULD NOT BE DETACHED. 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). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS MALFORMATION (AVM). ANCILLARY DEVICES INCLUDE A TERUMO PROGREAT 2.4F MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967009 ↗
• MalfunctionJan 18, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REPORTING THAT 4 CONCERTO COILS HAD RESISTANCE, DEPLOYED BECAME STUCK IN THE CATHETER. IT WAS UNKNOWN IF THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE. THE COILS WERE 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 13285326 ↗
• MalfunctionNov 18, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATING THERE WERE OVER FOUR ATTEMPTS MADE TO DETACH THE COIL USING THE INSTANT DETACHER. THERE WERE OVER THREE ATTEMPTS MADE WITH THE MANUAL METHOD. THERE WERE NO ISSUES ENCOUNTERED PRIOR TO THE COIL NON-DETACHMENT. THERE WAS NO PUSHWIRE DAMAGE OBSERVED AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12837644 ↗
• MalfunctionOct 1, 2021Migration; Migration

  MEDTRONIC RECEIVED INFORMATION THAT A CONCERTO COIL MIGRATED AFTER DEPLOYMENT AS IT WAS ATTACHED TO MICRO CATHETER EXITING PATIENT'S BODY. THE PATIENT WAS BEING TREATED FOR NEUROVASCULAR ABNORMALITIES (E.G. ARTERIOVENOUS MALFORMATIONS OR FISTULAE); PSEUDOANEURYSM. PATIENT'S BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE.  IT WAS INDICATED ALL PRODUCTS WERE PREPARED AS ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE COILS WAS POSITIONED AND LIBERATED. WHEN THE PHYSICIAN RETRACTED THE MICRO CATHETER THE COIL WAS ATTACHED TO IT EXITING THE PATIENTS BODY. NO SYMPTOMS WERE REPORTED. ANCILLARY DEVICES: REBAR 18 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563177 ↗
• MalfunctionJul 15, 2021Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12174523 ↗
• 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 12135032 ↗
• MalfunctionJun 7, 2021Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE COILS PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE RESISTANCE OCCURRED AT THE DISTAL END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11949989 ↗
• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  IT WAS REPORTED THE COIL WAS BEING USED AS PER THE IFU, BUT IT COULD NOT BE DETACHED EITHER INSTANT DETACHER NOR MANUAL METHOD. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769702 ↗
• MalfunctionMay 4, 2021Separation Failure; Separation Failure

  (B)(6) 2021 MPXR 830873 (FOR, HCP, REP): IT WAS REPORTED THE COIL WAS BEING USED AS PER THE IFU, BUT IT COULD NOT BE DETACHED EITHER INSTANT DETACHER NOR MANUAL METHOD. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITHTHE EVENT. (B)(6) 2021. E1 (HCP, REP, FOR): ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), INDICATED THE FOLLOWING WERE ALL UNKNOWN: HOW MANY DETACHMENT ATTEMPTS WERE MADE VIA INSTANT DETACHER, THE NUMBER OF DETACHMENT ATTEMPTS VIA MANUAL METHOD, LOT NUMBER OF INSTANT DETACHER, IF THERE ANY ISSUES PRIOR TO NON-DETACHMENT, AND IF THERE WAS ANY DAMAGE OBSERVED TO THE DEVICE AFTER REMOVAL. (B)(6) 2021. E2 (FOR, OTH): NO ADDITIONAL INFORMATION RECEIVED. (B)(6) 2021. E3 (OTH, FOR): NO ADDITIONAL INFORMATION RECEIVED. (B)(6) 2021. E4 (OTH, FOR): NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769566 ↗
• MalfunctionApr 23, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COILS HAD HIGH FRICTION IN THE MIDDLE OF THE MICROCATHETER, AND COULD NOT BE RELEASED. SEVERAL DETACHMENT ATTEMPTS WERE MADE USING THE INSTANT AND MANUAL DETACHMENT METHODS. THE PATIENT'S CONDITION NECESSITATING TREATMENT WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WAS NO DAMAGE TO THE CATHETER OR COIL. ANCILLARY DEVICES INCLUDE A 6F SHEATH, 5F COBRA GUIDE CATHETER, DIREXION 21 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716606 ↗
• MalfunctionApr 23, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE COILS HAD HIGH FRICTION IN THE MIDDLE OF THE MICROCATHETER, AND COULD NOT BE RELEASED. SEVERAL DETACHMENT ATTEMPTS WERE MADE USING THE INSTANT AND MANUAL DETACHMENT METHODS. THE PATIENT'S CONDITION NECESSITATING TREATMENT WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THERE WERE NO RELATED PATIENT SYMPTOMS. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. THERE WAS NO DAMAGE TO THE CATHETER OR COIL. ANCILLARY DEVICES INCLUDE A 6F SHEATH, 5F COBRA GUIDE CATHETER, DIREXION 21 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716591 ↗
• MalfunctionApr 22, 2021Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE COIL COULD NOT BE REMOVED, ALTHOUGH THE WIRE COULD BE BROKEN OFF AT THE BACK. THE COIL COULD NOT BE SET DOWN, EVEN WITH A CLAMP. THE COIL WAS ABLE TO BE REMOVED TOGETHER WITH THE SYSTEM, THE INTERVENTION WAS EXTENDED BY A MOMENT. IT WAS ALSO STATED THAT IF THE COIL HAD BEEN WITHDRAWN, IT COULD HAVE LOOSENED AND CLOSED ANOTHER VESSEL. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT, AND NO FURTHER EVENT INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706572 ↗
• MalfunctionApr 12, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION CLARIFIED THAT THE DEPLOYMENT ISSUE REPORTED WAS THAT THERE WAS RESISTANCE WITH THE COIL MIDWAY THROUGH DEPLOYMENT IN THE MICROCATHETER AND IT WASN'T ABLE TO BE ADVANCE FURTHER. UPON REVIEWING, THE DOCTOR ACKNOWLEDGED THAT A SMALLER MICROCATHETER SHOULD HAVE BEEN USED WITH THE CONTINUED SALINE FLUSH. IT WAS NOTED THAT THE DOCTOR WAS NEW TO USING CONCERTO COILS AND WAS HAPPY THAT THIS WAS THE REASON FOR THE COIL NOT BEING ABLE TO BE ADVANCED PROPERLY. ANCILLARY DEVICE: PROGREAT 2.7 MICROCATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653091 ↗
• MalfunctionJan 21, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS UNDERGOING EMBOLIZATION OF A TYPE 2 ENDOLEAK. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THREE DETACHMENT ATTEMPTS WERE MADE WITH AN INSTANT DETACHER, AND 6 DETACHMENT ATTEMPTS WITH A MANUAL DETACHMENT METHOD. THE DETACHER WORKED FINE FOR 6 COILS USED PRIOR TO DEPLOYMENT. PRIOR TO NON-DETACHMENT THE COIL WOULD NOT PASS THROUGH THE CLEAR PLASTIC TRANSPORT TUBE INTO THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND DEPLOYMENT WIRE FROM THIS TUBE AND BACK LOADED IT IN THE CLEAR TUBE TO FACILITATE DEPLOYMENT INTO THE MICROCATHETER. ANCILLARY DEVICES INCLUDE A PROGREAT 2.7FR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207344 ↗
• MalfunctionSep 3, 2020Incomplete or Missing Packaging; Detachment of Device or Device Component; Incomplete or Missing Packaging; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED TO THE PHYSICIAN CLARIFIED THAT THE COIL WAS, IN FACT, PRESENT DURING THE CASE. THE COIL PREMATURELY DETACHED WITHIN THE MICROCATHETER AFTER PULLING BACK AND READVANCING. THE COIL AND MICROCATHETER WERE THEN REMOVED TOGETHER. BOTH DEVICES WERE REPLACED AND THE COILING PROCEDURE WAS THEN ABLE TO BE COMPLETED WITHOUT FURTHER ISSUE. IT WAS REPORTED THAT THE PATIENT'S VESSEL ANATOMY WAS NOT TORTUOUS.

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

  MAUDE report 10488116 ↗
• MalfunctionMay 12, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORTED THAT TWO CONCERTO COILS WERE INSPECTED AND PREPPED PER THE IFU WITH NO ISSUES. THERE WAS NO PRODUCT ISSUE ALLEGED, BUT IT WAS ALSO STATED THE COILS FAILED. IT WAS THE ISSUE WITH BOTH COILS. THE COIL DID NOT PASS THROUGH THE MICRO-CATHETER. THEY PHYSICIAN DECIDED TO USE THE NEW CONCERTO INSTEAD OF THE FAILED COIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10047723 ↗
• MalfunctionMay 1, 2020Separation Failure; Separation Failure

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PHYSICIAN DID NOT USE THE INSTANT DETACHER IN THIS CASE, BUT MANUALLY DEPLOYED THE COIL USING THE HYPOTUBE BREAK METHOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10017564 ↗
• MalfunctionMar 18, 2020Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO COIL DID NOT DETACH DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9851225 ↗
• MalfunctionOct 22, 2019Separation Failure; Separation Failure

  MEDTRONIC RECEIVED A REPORT THAT THE CONCERTO HELIX COIL DID NOT DEPLOY. NO FURTHER INFORMATION WAS REPORTED, 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 9222027 ↗

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